[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nafld\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nafld":639},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,54,0,25,[9,48,73,96,129,154,182,204,231,251,277,298,319,343,362,393,413,432,455,481,505,526,548,574,609],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100223978",false,"NCT02193295","Reversal of Lipid-Induced Insulin Resistance","Inclusion Criteria:\n\n* Healthy, sedentary, non-smoking and not taking any medications other than birth control pills.\n* Hematocrit \\>35%\n* Subjects will have no systemic or organ disease including diabetes.\n* Subjects will have no history eating disorders.\n* Women must be using a form of birth control (sexual abstinence, birth control pills, Norplant, IUD or condoms) and will be studied between day 0 and 7 of their menstrual cycle.\n* Those who are taking birth control pills or have had a hysterectomy may be studied at any time.\n* Physical activity will be assessed using a standard questionnaire with an activity index cut off at 2.3.\n\nExclusion Criteria:\n\n* Any subject, who does not fit the inclusion criteria. Including history of eating disorders, any systemic and organ disease including diabetes.\n\nLactose intolerance Any blood count, clotting abnormalities HYpertriglyceridemeia (TG over 100 mg\u002FdL)\n\n* Hematocrit \\\u003C35%.\n* Women of childbearing potential, who are not using contraception (as mentioned above) or who are not abstinent.\n* Subjects who have a regular exercise regimen will not be enrolled.\n* Metal implants and\u002For body piercing, which cannot be removed before the MR studies.",true,"ALL","18 Years","90 Years",{"count":20,"type":21},250,"ESTIMATED","INTERVENTIONAL",[24],"NA","The purpose of this study is to examine whether weight reduction decreases intramyocellular (IMCL) and hepatic lipid content, and improves insulin sensitivity of muscle and fat tissue in people who are insulin resistant and have a family history of type 2 diabetes.\n\nHepatic mitochondrial oxidation will be assesses using a 3 hour triple tracer study (D7 glucose, 3-13C lactate and 13C4 beta-hydroxybutyrate).",[27,28],"Insulin Resistance","NAFLD",[30,31,32,33,34],"Weight Reduction","Caloric Restriction","Euglycemic Hyperinsulinemic Clamp","Magnetic Resonance Spectroscopy","PINTA","RECRUITING","2026-06-17",{"date":38,"type":39},"2026-06-22","ACTUAL",{"date":41,"type":39},"2002-10",{"date":43,"type":21},"2034-12",{"name":45,"class":46},"Yale University","OTHER",2,{"id":49,"slug":4,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":61,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100471832","NCT05424003","Randomized Double Blinded Placebo-Controlled w\u002FSemaglutide to Prevent Weight Gain After Liver Transplant","A Randomized Double Blinded Placebo-Controlled Trial of Semaglutide to Prevent Weight Gain Following Liver Transplantation","Inclusion Criteria:\n\n* Male or female age 18-75 years who received LT for any indication (i.e. NASH, hepatitis C, alcohol-induced cirrhosis, autoimmune hepatitis, etc.)\n* Liver transplant surgery within 8-24 weeks prior to randomization\n* Fasting glucose \\> 125 mg\u002FdL or presence of diabetes (HbA1c≥6.5% or use of diabetes medications) or pre-diabetes (HbA1c \\>5.7%)\n* Ability to provide informed consent\n* Discharged from the hospital following LT surgery\n* Tolerating diet\n* Normal graft function\\* (determined by treating hepatologist\u002Fsurgeon based on clinical status and hepatic panel)\n* Stable immunosuppression according the VCU (Virginia Commonwealth University) post-LT protocols \\*\\* (i.e. calcineurin inhibitors + mycophenolate)\n* Eligible female patients will be (1) non-pregnant, evidenced by a negative urine pregnancy test, (2) non-lactating, (3)surgically sterile or post-menopausal, or they will agree to continue to use an accepted method of birth control during the study\n\nExclusion Criteria:\n\n* BMI≤ 27kg\u002Fm2\n* GFR (Glomerular Filtration Rate) ≤ 25 ml\u002Fmin\u002F1.73m2\n* Type 1 autoimmune diabetes (by anti-GAD (glutamic acid decarboxylase) or history of ketoacidosis)\n* History of gastroparesis\n* Familial or personal history of medullary thyroid cancer or MEN (Multiple Endocrine Neoplasia) 2\n* History of pancreatitis\n* History of active malignancy post- LT with the exception of non-melanoma skin cancers\n* History of uncontrolled or unstable diabetic retinopathy or maculopathy\n* Acute cellular rejection\n* Hepatic artery thrombosis\n* Medical non-compliance\n* Active treatment with GLP (glucagon-like peptide)-1RA (receptor agonist) or SGLT (sodium-glucose cotransporter)-2 inhibitors at time of screening\n* History of hypersensitivity to semaglutide or its excipients\n* Women who are nursing, pregnant, or planning to become pregnant during the study, or are not using adequate contraceptive measures","75 Years",{"count":56,"type":21},50,[58],"PHASE2","In this study, semaglutide will be compared to placebo (a look-alike inactive substance, a \"sugar pill\") to determine if its use will prevent weight gain after liver transplantation (LT). In addition, researchers will be testing to determine if semaglutide prevents the development of Non-Alcoholic Fatty Liver Disease (NAFLD) after transplant through Magnetic Resonance Imaging (MRI) and laboratory results.",[28],[62],"Liver Transplant","2026-06-02",{"date":65,"type":39},"2026-06-04",{"date":67,"type":39},"2024-02-22",{"date":69,"type":21},"2026-08-01",{"name":71,"class":46},"University of Virginia",1,{"id":74,"slug":4,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":79,"minAge":17,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":72},"100514506","NCT05979389","Bicalutamide Therapy in Young Women With NAFLD and PCOS","Pilot Trial of Bicalutamide Versus Placebo in Reproductive-Aged Women With Nonalcoholic Fatty Liver Disease (NAFLD) and Polycystic Ovary Syndrome (PCOS)","Inclusion Criteria:\n\n* Women aged 18-42 years with hyperandrogenic PCOS\n* NASH identified on liver biopsy or probable NASH on transient elastography- controlled attenuation parameter (TE-CAP) with cutoffs defined as CAP score ≥270 decibel\u002Fm and TE score \\> 7.0 kPA or alanine aminotransferase ≥40 U\u002FL).\n\nExclusion Criteria:\n\n* Uncontrolled diabetes\n* Alcohol consumption \\>2 drinks per day for at least 3 consecutive months over the previous 5 years\n* Other chronic liver disease (i.e. hepatitis B virus, hepatitis C virus, autoimmune hepatitis) or cirrhosis from any cause\n* Recent or planned upcoming weight reduction surgery within five years of diagnosis of biopsy-confirmed NASH\n* HIV infection\n* Drugs associated with fatty liver (i.e. amiodarone, methotrexate, systemic glucocorticoids, tamoxifen, anabolic steroids, valproic acid) for more than 4 weeks prior to baseline or during study\n* Recent, current, or planned upcoming pregnancy or current perimenopausal status\n* Renal impairment (glomerular filtration rate \\\u003C45 ml\u002Fmin\u002F1.73m or potassium levels \\> 5.0 mmol\u002FL)\n* Androgen receptor antagonist use (i.e. spironolactone or flutamide) for more than 3 months within one year prior to baseline","FEMALE","42 Years",{"count":56,"type":21},[83],"PHASE1","Nonalcoholic steatohepatitis (NASH), or fat-related liver inflammation and scarring is projected to be the leading cause of cirrhosis in the United States (U.S.) within the next few years. Women are at disproportionate risk for NASH, with approximately 15 million U.S. women affected. There is an urgent need to understand risk factors for NASH and its progression in women, and sex hormones may provide a missing link. This study will study the contribution of androgens to liver injury and progression in PCOS and mechanistic role of dysregulated lipid metabolism and visceral adiposity in this process. Such findings will provide the rationale for future efficacy studies evaluating selective androgen receptor (AR) antagonism for NASH in PCOS, or alternatively, the need to directly target visceral adiposity or lipid-specific pathways as part of a precision medicine approach to halt fibrosis progression in the nearly 5 million young women with PCOS and NAFLD in the U.S., who remain at increased risk for early onset and progressive liver disease.",[28,86],"PCOS","2026-05-26",{"date":89,"type":39},"2026-05-29",{"date":91,"type":39},"2024-02-14",{"date":93,"type":21},"2028-08",{"name":95,"class":46},"University of California, San Francisco",{"id":97,"slug":4,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":103,"targetDuration":4,"studyType":22,"phases":105,"briefSummary":106,"conditions":107,"keywords":115,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":47},"100561325","NCT06588699","Digoxin In NASH (CODIN)","Clinical Trial of Oral Digoxin In NASH (CODIN)","CODIN","Inclusion Criteria\n\n* Stable body weight (≤ 5% self-reported change in body weight) in the 30 days prior to screening\n* Biopsy-confirmed non-alcoholic steatohepatitis (NASH) as defined by the NASH clinical research network (NASH CRN) histological scoring system, with non-alcoholic fatty liver disease score (NAS) ≥4 and with a score ≥1 for each of the three components (steatosis, hepatocellular ballooning, and lobular inflammation) on a liver biopsy performed within 6 months of screening\n* Histological fibrosis stage 2 or 3 based on pathologist evaluation of a liver biopsy performed up to 6 months before screening\n* Agrees to have a liver biopsy performed to assess baseline histology if one has not been performed up to 6 months before screening, and at 24 weeks after randomization Exclusion Criteria\n\nLiver-related:\n\n* Documented causes of chronic liver disease other than NASH\n* History or clinical evidence of cirrhosis or portal hypertension\n* History of positive HBsAg, positive anti-HIV, positive HCV-RNA\n* AST or ALT \\> 5 times upper limit of normal (ULN) at screening\n* Total bilirubin \\> 1.5 mg\u002FdL at screening unless conjugated bilirubin is \\\u003C 1.5 × ULN\n* International normalized ratio (INR) \\> 1.3 at screening\n* Known or suspected alcohol use \\> 20 g\u002Fday for women or \\> 30 g\u002Fday for men\n* Treatment initiation or dose adjustment of vitamin E, pioglitazone, GLP-1RA, or SGLT-2 inhibitors within 30 days of signing the informed consent or 30 days prior to liver biopsy\n* Treatment initiation or anticipated treatment (\\>14 consecutive days) with medications known to affect steatosis (e.g., systemic corticosteroids, tamoxifen, valproic acid, methotrexate, tetracycline or amiodarone) within 30 days of signing the informed consent or 30 days prior to liver biopsy\n\nCardiac related:\n\n* Heart rate less than 60 bpm at screening (visit 1) or at baseline (visit 2)\n* Current diagnosis of severe aortic valve disease\n* History of Accessory arterio-ventricular pathway (e.g., Wolf-Parkinson-White syndrome)\n* History of complete heart block or second degree arterio-ventricular block without pacemaker or implantable cardiac device\n* Current diagnosis of permanent atrial fibrillation\n* Any of the following within the previous 6 months of signing informed consent: myocardial infarction, percutaneous intervention, pacemaker\u002Fimplantable cardiac device implantation, cardiac surgery, or stroke\n* Current use of the following medications: inotropic drugs such as (dopamine, dobutamine, noradrenaline, milrinone), anti-arrhythmics (amiodarone, dofetilide, sotalol, dronedarone, digoxin), parathyroid hormone analog (teriparatide), sympathomimetics (epinephrine, norepinephrine, dopamine), neuromuscular blocking agents (succinylcholine), calcium supplement, nondihydropyridine calcium channel blockers, ivabradine, and disulfiram.\n\nObesity related:\n\n* Treatment initiation (in the 30 days prior to signing the informed consent or 30 days prior to liver biopsy) with orlistat, zonisamide, topiramate, phentermine, bupropion, and naltrexone alone or in combination or any other medication that could promote weight loss in the opinion of the investigator\n* Participation (in the 30 days prior to signing the informed consent or 30 days prior to liver biopsy) in an organized diet-based weight reduction program (e.g., WeightWatchers, Optifast)\n* Recent surgical treatment (\\\u003C6 months of signing informed consent) for obesity\n\nGeneral safety related:\n\n* Presence or history of malignant neoplasms (in the past 5 years prior to screening), except basal and squamous cell skin cancer and any carcinoma in-situ\n* Surgery scheduled or anticipated during the trial period, except for minor surgical procedures, in the opinion of the investigator\n* Language barrier, mental incapacity, unwillingness, or inability to adequately understand or comply with study procedures\n* Known or suspected hypersensitivity to the trial product or related products including allergy to milk, egg, soy, peanuts, and sulfites\n* Recent participation (within 90 days prior to signing the informed consent) in any clinical trial of an approved or non-approved investigational medicinal product\n* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method\n* Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of eGFR \\\u003C 30 ml\u002Fmin\u002F1.73 m2\n* TSH \\> 6 mIU\u002FL or \\\u003C 0.4 mIU\u002FL at screening\n* Current use of the following medications: calcium supplementation, parathyroid hormone analog (teriparatide), neuromuscular blocking agents (succinylcholine) and disulfiram.\n* Claustrophobia to an extent that would prevent tolerance of MRI\n* Metallic implant that would prevent MRI examination including, metallic foreign body, aneurysm clips, vascular grafts or cardiac implants, neural stimulator, cochlear implant, metallic contraceptive device, body piercing that cannot be removed, cochlear implant, or any other contraindication to MRI",{"count":104,"type":21},144,[58],"Nonalcoholic steatohepatitis (NASH) is a severe subtype of nonalcoholic fatty liver disease (NAFLD) which affects 1 in 3 Americans. The mainstay of treatment for NASH, which was recently renamed metabolic associated steatohepatitis (MASH), involves lifestyle interventions to promote weight loss and to treat comorbidities such as hypertension, hyperlipidemia, and diabetes mellitus. There is thus, a substantial unmet need for pharmacological therapies that are effective for treatment of NASH, especially in those with fibrosis which is the main predictor of disease progression and mortality among NASH patients. The repurposing of presently available drugs would help expedite the search for agents effective in treating NASH. The cardiac glycoside digoxin is currently used in the management of heart failure and supraventricular tachyarrhythmias. The investigators and other groups have demonstrated that digoxin protects the liver from various forms of acute and chronic liver injury. The investigators preliminary data in healthy human subject indicate an immunomodulatory effect of low dose oral digoxin with no adverse side effects. This study proposes to demonstrate the clinical benefits of digoxin on NASH and on liver fibrosis, thus supporting the repurposing of digoxin as treatment for NASH.",[108,28,109,110,111,112,113,114],"NASH","MASH - Metabolic Dysfunction-Associated Steatohepatitis","Mash","MASH With Fibrosis","MASLD","Fatty Liver Disease","Fatty Liver Disease, Nonalcoholic",[108,116,117,118,119,120,121,28],"MASH","Metabolic dysfunction associated steatohepatitis","Digoxin","Drug repurposing","Liver fibrosis","Fatty liver disease","2026-05-22",{"date":87,"type":39},{"date":125,"type":39},"2025-06-05",{"date":127,"type":21},"2029-01",{"name":45,"class":46},{"id":130,"slug":4,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":22,"phases":137,"briefSummary":138,"conditions":139,"keywords":142,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":72},"100507233","NCT05884723","Preoperative Ketogenic Diet for Reduction of Hepatic Steatosis","Implementation of a Preoperative Ketogenic Diet for Reduction of Hepatic Steatosis Prior to Hepatectomy: a Randomized Control Trial","Inclusion Criteria:\n\n* Patients 18 years of age or older undergoing any type of liver resection (e.g. wedge, formal hepatectomy), either open or laparoscopic, for colorectal liver metastases (CRLM)\n* Patients with evidence of hepatic steatosis on pre-operative imaging (CT or MR) or biopsy.\n* Ability to use an app based nutritional program to track macronutrient uptake throughout the dietary intervention.\n\nExclusion Criteria:\n\n* Patients undergoing liver resection for any other indication\n* Patients on sodium glucose co-transporter 2 (SGLT-2) inhibitors (these are contraindicated with a ketogenic diet).\n* Patients without evidence of hepatic steatosis.\n* Patients with evidence of liver fibrosis or cirrhosis on preoperative bloodwork or imaging.\n* Patients with alcohol-related hepatic steatosis.\n* Patients with a known bleeding disorder.",{"count":136,"type":21},124,[24],"Non-alcoholic fatty liver disease is becoming increasingly common in Canada and throughout the world. Fatty liver can increase the risks of perioperative complications for those who need liver surgery. A ketogenic diet is low in carbohydrates and can be very effective in reducing liver fat content. The purpose of this randomized control trial is to compare the effect of a short duration (4 week) preoperative ketogenic diet on operative and disease outcomes in patients undergoing liver surgery. One arm will be randomized to the ketogenic diet and the other will receive standard of care pre-operative dietary consultation.",[140,141,28],"Liver Steatoses","Liver Metastasis Colon Cancer",[143,28,144],"ketogenic diet","colorectal liver metastases","2026-05-15",{"date":147,"type":39},"2026-05-19",{"date":149,"type":39},"2024-05-01",{"date":151,"type":21},"2032-12",{"name":153,"class":46},"Anton Skaro",{"id":155,"slug":4,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":16,"minAge":160,"maxAge":161,"enrollmentInfo":162,"targetDuration":4,"studyType":22,"phases":164,"briefSummary":165,"conditions":166,"keywords":167,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":47},"100504020","NCT05842850","Non-alcoholic Fatty Liver Disease in Low Birth Weight Individuals","Increased Risk of Non-alcoholic Fatty Liver Disease in Low Birth Weight Individuals - Reversibility and Mechanistic Studies.","Inclusion Criteria:\n\n* subjects with NAFLD (liver fat content ≥5% liver fat content verified on MRS in the screening NAFLD study)\n\nExclusion Criteria:\n\n* BMI\\\u003C18.5 and BMI\\>30 kg\u002Fm2\n* Family history of diabetes (siblings, parent, and grandparents)\n* Disease\u002Fmedication known to affect primary outcome\n* Self-reported high physical activity level\n* Alcohol intake above general recommendations.\n* Metabolic\u002Fliver disease\n* Weight gain\u002Floss of \\>3 kg within the past 6 months","35 Years","40 Years",{"count":163,"type":21},8,[24],"The investigators will conduct a proof-of-principle 4-weeks low-calorie diet (LCD) intervention study in low birth weight (LBW) subjects and normal birth weight (NBW) controls with documented (MR scan) liver fat content equal to or above 5%. The investigators will provide extended in-depth mechanistic insight into the role of impaired subcutaneous adipose tissue (SAT) expandability in ectopic fat deposition before and after LCD.",[28],[168,169,170,171,172],"Adipose tissue biology","Caloric restriction","Insulin resistance","Energy expenditure","Insulin secretion","2026-04-28",{"date":175,"type":39},"2026-05-04",{"date":177,"type":39},"2026-01-01",{"date":179,"type":21},"2026-12",{"name":181,"class":46},"Steno Diabetes Center Copenhagen",{"id":183,"slug":4,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":4,"eligibilityCriteria":187,"healthyVolunteers":11,"sex":79,"minAge":17,"maxAge":80,"enrollmentInfo":188,"targetDuration":190,"studyType":191,"phases":4,"briefSummary":192,"conditions":193,"keywords":194,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":47},"100525632","NCT06124261","Androgens and NAFLD Longitudinal Cohort Study","Androgens and Nonalcoholic Fatty Liver Disease (NAFLD) In Reproductive-Aged Women With and Without Polycystic Ovary Syndrome (PCOS)","Inclusion Criteria:\n\n* Metabolic associated steatohepatitis (MASH) (formerly NASH)\n* PCOS\n* Non-PCOS\n\nExclusion Criteria:\n\n* High levels of alcohol use (more than 7 drinks a week)\n* Current pregnancy\n* Other causes of hepatic steatosis\n* Weight loss of more than 10% body weight in the last 6 months",{"count":189,"type":21},150,"3 Years","OBSERVATIONAL","The researchers want to learn how androgens, a type of sex hormone, might affect nonalcoholic fatty liver (NAFLD) in young women over time. NAFLD happens when fat builds up in the liver which can cause damage to the liver such as inflammation or scarring.\n\nYoung women with a condition called polycystic ovary syndrome (PCOS) have a high risk for NAFLD, and they often have high androgen levels too. So the researchers are recruiting young women with PCOS as well as those without PCOS, and will compare changes in NAFLD over time between young women with and without PCOS.\n\nThis study is funded by the National Institutes of Health",[86,28,108],[195],"Androgen","2026-04-09",{"date":198,"type":39},"2026-04-13",{"date":200,"type":39},"2024-01-22",{"date":202,"type":21},"2028-12",{"name":95,"class":46},{"id":205,"slug":4,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":4,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":210,"enrollmentInfo":211,"targetDuration":4,"studyType":22,"phases":213,"briefSummary":214,"conditions":215,"keywords":217,"overallStatus":222,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":4},"100559422","NCT06563921","RE and Probiotics in MAFLD\u002FNAFLD","PRObiotic Mixed With Exercise THErapy USe in MAFLD (PROMETHEUS in MAFLD)","Study population: Patients diagnosed with non-alcoholic or metabolically mediated fatty liver disease (NAFLD\u002FMAFLD), including the inflammatory form (NASH), confirmed by imaging (ultrasound, MRI-PDFF) or histopathological (liver biopsy) methods.\n\nInclusion criteria:\n\n* Diagnosis of NAFLD\u002FMAFLD or NASH (imaging or histological confirmation of fatty liver disease, e.g., ultrasound, MRI-PDFF, biopsy)\n* Age 18-60 years\n* Ability to understand the study procedures and provide informed consent.\n* Stable clinical condition for at least 3 months prior to study initiation.\n\nExclusion criteria:\n\n* Lack of fluency in English or Polish\n* Significant (structural) limitation of upper and\u002For lower limb mobility\n* Pregnancy or breastfeeding\n* Inability to understand instructions\n* Shift work\n* Participation in any study or research project within the last 3 months\n* Participation in an interventional drug study within the last 3 months\n* Participants with hepatic steatosis and regular alcohol consumption \\> 30 g\u002Fday\n* Individuals with any concomitant liver disease (viral hepatitis, drug-induced liver injury, metabolic\u002Fgenetic diseases (e.g., Wilson's disease))\n* Anticoagulant\u002Fantiplatelet therapy, antithrombotic therapy, immunosuppressive medications, prolonged immunosuppression (e.g., recent cytotoxic chemotherapy, HIV infection with CD4 count \\\u003C 240), antibiotics, corticosteroids, valproic acid, amiodarone, tamoxifen within 3 months prior to study enrollment\n* Use of medications such as steroids, methotrexate, metformin\n* Use of agents such as vitamin E, omega-3 fatty acids, or medications with evidence of an effect on NAFLD (pioglitazone, GLP-1 analogues, dipeptidyl peptidase IV inhibitors, ursodeoxycholic acid)\n* Active or previous history of invasive cancer (excluding curatively treated carcinoma in situ \\[e.g., cervical\\] or benign skin cancer), unless complete remission has been achieved\n* Regular use of probiotic or prebiotic supplements within 3 months prior to study enrollment\n* Known allergy to probiotics\n* History of using an alternative diet within 3 months prior to study enrollment or changing diet during study entry\n* Previous surgery (bariatric surgery, gastric or intestinal resection)\n* Parenteral nutrition (TPN) within the last 6 months\n* Insulin therapy\n* Uncontrolled diabetes\n* Cardiovascular disease (e.g., uncontrolled blood pressure, coronary artery disease, NYHA class III-IV heart failure, severe arrhythmias, orthostatic intolerance)\n* Nervous system disorders\n* Cognitive impairment and dementia\n* Osteoporosis\u002Fosteopenia\n* Active thyroid disease\n* Cushing's syndrome\n* Any implanted battery-powered device (e.g., AICD, pacemaker, cardiac rhythm recorder, cochlear implant)","60 Years",{"count":212,"type":21},180,[24],"This project aims to evaluate the roles of the autonomic nervous system (ANS) and gut microbiota as correlates of clinical improvement in metabolic dysfunction-associated fatty liver disease (MAFLD) and non-alcoholic fatty liver disease (NAFLD) in response to a therapeutic regimen comprising resistance exercise and probiotic supplementation. The primary objective is to investigate the effects of these non-pharmacological interventions on MAFLD\u002FNAFLD and to identify patient phenotypes based on baseline ANS profiles and gut microbiota composition that predict clinical responses.",[108,28,216],"MAFLD",[108,216,28,218,219,220,221],"Probiotics","Resistance training","Gut microbiota","Hypertrophy training","NOT_YET_RECRUITING","2026-04-07",{"date":196,"type":39},{"date":226,"type":21},"2026-04-10",{"date":228,"type":21},"2036-04-10",{"name":230,"class":46},"Nicolaus Copernicus University",{"id":232,"slug":4,"hasResults":11,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":237,"targetDuration":4,"studyType":191,"phases":4,"briefSummary":239,"conditions":240,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":72},"100632830","NCT07518784","Accurate Point of Care Liver Disease Diagnostics (Phase 2)","Accurate Point of Care Liver Disease Diagnostics","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Known or clinically suspected MASLD\n* BMI greater than 27 kg\u002Fm\\^2 and less than 45 kg\u002Fm\\^2 at the time of referral\n* Ability to lie on LiverScope® device table for about 60 minutes\n* Ability to hold breath repeatedly for about 20 seconds during MR and LiverScope® exams\n* Willing and able to undergo all study procedures\n\nExclusion Criteria:\n\n* UCSD study personnel or Livivos study personne\n* Contraindications to MR\n* Potential participant states that she knows that she is pregnant, thinks she may be pregnant, or states that she is trying to become pregnant.\n* Known chronic liver disease other than MASLD",{"count":238,"type":21},26,"This research study is being conducted to find out more about techniques to non-invasively evaluate liver disease. This is the second phase of a project in which we are testing a new technology to evaluate the liver (LiverScope®). We will compare LiverScope® to other methods to evaluate the liver, including advanced conventional liver MR exams. MR exams are common exams used to monitor MASLD (also known as NAFLD). Conventional MR scanners use magnetic fields and radio waves to make pictures of the liver. LiverScope® is a small, portable MR-based device that uses similar, but simplified technology, and can be used on top of an exam table in an outpatient setting. LiverScope® currently is not approved for clinical use.\n\nIn this second phase of the study, we took what we learned in the first phase to optimize the LiverScope® device and are now testing to see how LiverScope® measurements compare to MR after these optimizations.\n\nStudy participants will be asked to complete a one-time visit which includes:\n\n* LiverScope exam\n* MR exam\n* FibroScan exam (optional)\n* Blood draw\n* Completion of study questionnaires",[112,241,28,242],"MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)","NAFLD (Nonalcoholic Fatty Liver Disease)","2026-04-01",{"date":196,"type":39},{"date":246,"type":21},"2026-04-08",{"date":248,"type":21},"2026-06-30",{"name":250,"class":46},"University of California, San Diego",{"id":252,"slug":4,"hasResults":11,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":256,"eligibilityCriteria":257,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":258,"enrollmentInfo":259,"targetDuration":4,"studyType":22,"phases":261,"briefSummary":262,"conditions":263,"keywords":265,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":72},"100530445","NCT06186869","Effects of Two Different Exercise Programs and Diet in Obese Subjects With NAFLD","Effects of Two Different Exercise Programs Combined With the Mediterranean Diet on Inflammatory Status in Subjects With Obesity and NAFLD","Obesity_AF","Inclusion Criteria:\n\n* BMI ≥ 30 kg\u002Fm2 or an abdominal circumference (waist) \\> 94 cm in men and \\> 80 cm in women (IDF criteria for the definition of abdominal obesity) with or without the characteristics that characterise metabolic syndrome\n* Age range 18-65 years, both sexes\n* Diagnosis of hepatic steatosis, formulated on the basis of recognised criteria (fibroscan (CAP (controlled attenuation parameter) \\> 238 dB\u002Fm)).\n\nExclusion Criteria:\n\n* Normal and underweight subjects\n* Presence of any pathology that may influence the presence of steatosis apart from pathologies that are inclusion criteria, neurological and psychiatric pathologies, gastrointestinal, oncological and cardiovascular diseases\n* Pregnancy or breastfeeding\n* Subjects with osteoarticular pathologies that may prevent regular exercise\n* Inability to quantify the degree of NAFLD by Fibroscan\n* Person not in possession of a medical certificate of fitness for non-competitive physical activity.","65 Years",{"count":260,"type":21},90,[24],"The aim of the study is to estimate the effectiveness of two different exercise programs combined with the Mediterranean diet versus diet alone on inflammatory status in subjects aged 18-65 years with obesity (BMI\\>30) and Non-Alcoholic Fatty Liver Disease (NAFLD) (CAP \\>248 dB\u002Fm).",[264,28],"Obesity",[264,266,267,28],"Physical Exercise","systemic inflammation","2026-03-24",{"date":270,"type":39},"2026-03-27",{"date":272,"type":39},"2023-10-02",{"date":274,"type":21},"2026-12-23",{"name":276,"class":46},"Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis",{"id":278,"slug":4,"hasResults":11,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":4,"eligibilityCriteria":282,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":283,"targetDuration":4,"studyType":22,"phases":285,"briefSummary":286,"conditions":287,"keywords":288,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":72},"100541654","NCT06332677","Target of Suv420h1\u002F2 in Hepatocytes","Targeting the Epigenetic Regulators Suv420h1\u002F2 in Hepatocytes to Treat Nonalcoholic Fatty Liver Disease","Inclusion Criteria:\n\nWe will analyse data and samples from subjects with the following criteria:\n\n* Subjects aged\\>18;\n* Subjects who have already given their consent to genetic analysis and whose samples and data have already been collected as part of the SERENA, REASON and MAFALDA studies;\n* Subjects who have given their consent to participate in this study.\n\nIn particular, subjects with the following characteristics were included respectively:\n\n* in the SERENA study:\n\n  1. Diagnosis of NAFLD\n  2. Age between 45 and 75 years old\n  3. Any of the following criteria:\n\n     1. F3-F4 fibrosis, determined histologically, or by non-invasive techniques, or evidence of cirrhosis deriving from biochemical tests or imaging methods;\n     2. Family history of related first-degree primary liver cancer, or carrier status of rare mutations associated with the development of HCC (such as mutations in APOB and TERT)\n     3. Male patient with type 2 diabetes or obesity carrying at least three genetic variants in PNPLA3, TM6SF2, MBOAT7.\n* in the REASON study:\n\nPatients aged\\>18, who have given their consent to participate in the study, who underwent the fol- lowing procedures:\n\n* liver biopsy for suspected non-alcoholic steatohepatitis (NASH) at the time of diagnosis;\n* liver resection for hepatocarcinoma, other liver lesions (including secondaries from other neo- plasms and benign focal lesions, which will allow obtaining healthy starting liver tissue), biopsies of whole liver explants obtained at the time of liver transplantation AND cholecystectomies.\n* In the MAFALDA study:\n\nPatients undergoing bariatric surgery for grade 3 obesity (BMI ≥40 Kg\u002Fm2) or grade 2 obesity plus:\n\n* metabolic comorbidities (uncontrolled hypertension, diabetes, dyslipidemia);\n* lack of contraindication to surgery (e.g. advanced liver disease with portal hypertension);\n* willingness to sign an informed consent.\n\nExclusion Criteria:\n\n* Individuals not reporting one of the inclusion criteria listed above or reporting at-risk alcohol intake (\\>30\u002F20 g\u002Fday in M\u002FF), viral and autoimmune hepatitis or other causes of liver disease will be ex- cluded.",{"count":284,"type":21},260,[24],"Nonalcoholic fatty liver disease (NAFLD) is globally the leading cause of liver disease and frequently progresses to cirrhosis and liver cancer. The identification of effective drugs is the main unmet clinical need. Changes in liver histones methylation accompanies the development and progression of NAFLD. Our preliminary data demonstrate that inactivation of the methyltransferases SUV420H1\u002F2 in hepatocytes protects mice against NAFLD. In this project we propose to examine the relevance of these findings by evaluating the impact of genetic deletion of hepatic SUV420H1\u002F2 in mice fed a steatogenic diet. To further evaluate the potential for clinical translation of these results, we will next 1) evaluate the expression of SUV420H1\u002F2 in human liver transcriptomic data and 2) analyze the impact of genetic variations on disease outcomes in population-based cohorts; 3) test an innovative therapeutic approach based on hepatocyte-targeted antisense oligonucleotides downregulating SUV420H1\u002F2 in human liver organoids\u002Fassembloids.",[28],[289],"epigenetic","2026-03-23",{"date":270,"type":39},{"date":293,"type":39},"2023-03-01",{"date":295,"type":21},"2027-04-30",{"name":297,"class":46},"Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico",{"id":299,"slug":4,"hasResults":11,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":303,"eligibilityCriteria":304,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":305,"enrollmentInfo":306,"targetDuration":4,"studyType":191,"phases":4,"briefSummary":308,"conditions":309,"keywords":4,"overallStatus":222,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":317,"locationsCount":72},"100591588","NCT06982378","GLP-1 RA on Liver OMICS in MASLD","Effect of Glucagon-like Peptide -1 Receptor Agonist on Liver Tissue and Plasma Lipids in MASLD","OMICS in MASLD","Inclusion Criteria:\n\n* known diagnosis of MASLD by histology, also have diabetes\u002F obesity\n* on treatment with GLP-1 RA at stable dose\n\nExclusion Criteria:\n\n* unable to have a liver biopsy, recent change in medication for diabetes or hyperlipidemia\n* on immunosuppression, liver or kidney transplant\n* pregnancy","80 Years",{"count":307,"type":21},30,"In patients with type II diabetes mellitus (T2DM) and obesity, an excess plasma-free fatty acid is found with an associated increased lipid accumulation in adipocytes and liver tissue. Lipid droplet accumulation in the hepatocytes is an initial step in the development of metabolic dysfunction associated steatotic liver disease (MASLD. Insulin resistance, which is associated with T2DM, mediates the inflammation of these lipids, resulting in the progression of MASLD to metabolic dysfunction associated steatotic hepatitis (MASH). Hence, in T2DM, obesity, and MASLD, changes in the lipid profile occur, and they are interrelated.\n\nIn this study, we aim to assess improvement in the lipidomic, its associated metabolic changes and evaluate the co-regulated genes in the liver tissue among patients with MASLD with intervention with GLP-1 RA, which has shown to benefit T2DM and obesity.",[28,310,264],"Diabetes","2026-03-08",{"date":313,"type":39},"2026-03-10",{"date":315,"type":21},"2026-07",{"date":202,"type":21},{"name":318,"class":46},"Medical College of Wisconsin",{"id":320,"slug":4,"hasResults":11,"nctId":321,"briefTitle":322,"officialTitle":322,"acronym":323,"eligibilityCriteria":324,"healthyVolunteers":11,"sex":16,"minAge":325,"maxAge":326,"enrollmentInfo":327,"targetDuration":4,"studyType":22,"phases":329,"briefSummary":330,"conditions":331,"keywords":4,"overallStatus":222,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":335,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":72},"100352332","NCT03867487","SGLT2 Inhibitors as a Novel Treatment for Pediatric Non-Alcoholic Fatty Liver Disease","SLIDE","Inclusion Criteria:\n\nFor clinical referral to screening visit:\n\n1. Age: 12 to \\\u003C20 years old\n2. Diagnosis of Obesity: BMI-percentile \\>95th (using age- and sex- based Center for Disease Control definitions) or BMI ≥30 kg\u002Fm2\n3. Elevated alanine aminotransferase (ALT) more than twice the upper limit of normal by gender (≥44 U\u002FL for girls, ≥50 U\u002FL for boys) within 3 months prior to screening (used for historic ALT value) OR diagnosis of NAFLD from ultrasound, MRI, or participants with biopsy-proven NASH within 12 moths of screening\n4. History of lifestyle modification to treat obesity or NAFLD\n\nTo be obtained at screening visit:\n\n1. Confirmation of Obesity\n2. Tanner stage 2,3,4 or 5;\n3. Normal fasting glucose tolerance (fasting blood glucose \\\u003C100 mg\u002FdL)\n4. If Screening ALT is used as inclusion criteria \\[if \\> 2x historic ALT value (historical value obtained clinically within 12 months of screening visit), repeated after 4 weeks \\[unable to randomize until completed\\]\\]. If the repeat ALT is more than 50% increased or decreased over the screening ALT, a third ALT should be obtained. If a third ALT is not within 50% of the previous value, then the subject is ineligible but may be screened at a later date. If ALT is not used:\n\n   * An ultrasound will be done to diagnose NAFLD if the diagnosis has not previously been made by ultrasound, MRI or biopsy\n   * A MRI-derived HFF ≥ 5.5%\n5. Willingness to adhere to lifestyle considerations throughout the study\n\nExclusion Criteria:\n\n1. ALT \\> 250U\u002FL at screening\n2. History of significant alcohol intake or current use\n3. Impaired fasting glucose (\\>100 mg\u002FdL)\n4. Diabetes (type 1 or 2)\n5. Current or recent (\\\u003C6 months prior to enrollment) use of weight loss medication(s)\n6. Vitamin E supplementation\n7. Previous bariatric surgery\n8. Use of metformin\n9. Prior use of empagliflozin\n10. Lower limb infection\u002Fulceration within 3 months of screening\n11. Metal or magnetic implants, devices or objects inside of or on the body, which are not MRI compatible\n12. Structural and functional urogenital abnormalities, that predispose for urogenital infections\n13. Recent initiation (\\\u003C3 months prior to enrollment) of anti-hypertensive or lipid medication(s)\n14. Major psychiatric disorder\n15. Known hypothalamic or pituitary dysfunction\n16. Current pregnancy or plans to become pregnant\n\n    * Females unwilling to be tested for pregnancy\n    * Females who are sexually active and not protected by an effective method of birth control (e.g. IUD or medication or patch)\n17. Tobacco use\n18. Significant liver dysfunction (levels \\>5 times the upper limit of normal (ULN)):\n\n    * ALT (ULN = 50 U\u002FL)\n    * AST (ULN = 48 U\u002FL)\n    * GGT (ULN = 48 U\u002FL)\n    * ALP (ULN = 115 U\u002FL)\n19. Platelets \\\u003C 150,000 cells\u002Fmm3\n20. Total bilirubin ≥ 1.3 mg\u002FdL\n21. INR ≥ 1.3\n22. Albumin \\\u003C3.2 g\u002FdL\n23. Gilbert's Syndrome\n24. Any known causes of liver disease (except NAFLD and NASH)\n25. Significant renal dysfunction (estimated glomerular filtration rate \\[eGFR\\] \\\u003C 80 mL\u002Fmin\u002F1.73 m2),\n26. Diagnosed monogenic obesity\n27. History of cancer\n28. Untreated thyroid disorder\n29. History of decompensation events (ascites, variceal bleeding, hepatic encephalopathy, or hepatocellular carcinoma)\n30. Current or recent (\\\u003C6 months prior to enrollment) use of medication(s) associated with weight gain (e.g. atypical anti-psychotics).","12 Years","20 Years",{"count":328,"type":21},40,[58],"This study is a randomized, double-blind, placebo-controlled trial specifically designed to evaluate the preliminary feasibility, initial efficacy and safety of SGLT2 inhibitors for treating NAFLD in adolescents with obesity.",[332,28,333],"Non-Alcoholic Fatty Liver Disease","Pediatric NAFLD","2026-01-16",{"date":336,"type":39},"2026-01-20",{"date":338,"type":21},"2027-05-01",{"date":340,"type":21},"2028-02-01",{"name":342,"class":46},"Justin Ryder",{"id":344,"slug":4,"hasResults":11,"nctId":345,"briefTitle":346,"officialTitle":347,"acronym":4,"eligibilityCriteria":348,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":258,"enrollmentInfo":349,"targetDuration":4,"studyType":22,"phases":351,"briefSummary":352,"conditions":353,"keywords":4,"overallStatus":222,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":355,"startDateStruct":357,"completionDateStruct":358,"leadSponsor":360,"locationsCount":72},"100616807","NCT07310407","Rutin and Vitamin C in Patients With Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)","Evaluation of the Effect of Rutin and Vitamin C in Patients With Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)","Inclusion Criteria:\n\n* Confirmed diagnosis of Metabolic-Associated Steatotic Liver Disease (MASLD).\n\nExclusion Criteria:\n\n* HCV infection.\n* HBV infection.\n* Patients with a history of significant alcohol consumption.\n* Autoimmune hepatitis.\n* Celiac disease (CD).\n* Wilson's disease (WD).\n* Haemochromatosis.\n* Drugs: Tamoxifen, Valproic acid, Amiodarone, Methotrexate, steroids and immunosuppressive agents, oral contraceptive pills, or drugs that can affect liver profile.\n* Hypo or hyper thyroidism.\n* Bypass surgeries.\n* TPN (Total Parenteral Nutrition).\n* Pregnant individuals or patients planning to become pregnant.",{"count":350,"type":21},120,[58],"evaluate the combined effects of Rutin and Vitamin C versus Vitamin C alone on selected oxidative stress markers, inflammation, hepatic steatosis regression, and associated metabolic parameters in patients with MASLD",[28],"2025-12-16",{"date":356,"type":39},"2025-12-30",{"date":177,"type":21},{"date":359,"type":21},"2027-03-01",{"name":361,"class":46},"Ain Shams University",{"id":363,"slug":4,"hasResults":11,"nctId":364,"briefTitle":365,"officialTitle":366,"acronym":367,"eligibilityCriteria":368,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":369,"enrollmentInfo":370,"targetDuration":4,"studyType":22,"phases":371,"briefSummary":372,"conditions":373,"keywords":376,"overallStatus":222,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":72},"100570332","NCT06705868","Chrononutrition\u002F Chronotoxicity Intervention in People With Metabolic-associated Steatotic Liver Disease.","Time-restricted Eating in Patients With Metabolic-associated Steatotic Liver Disease . CHRONOMASLD: A Chrononutrition\u002FChronotoxicity Randomized Controlled Trial.","CHRONOMASLD","Inclusion Criteria:\n\n1. Body mass index 25 (±0,5)-45(±0,5) kg\u002Fm2\n2. Clinical diagnosis of MASLD, not excluding undiagnosed NASH or with NASH stage F0-F1\n3. Self-reported habitual eating period more than or equal to 14 h per day, BUT NOT LESS.\n4. Cyprus inhabitants of for at least 1 year\n5. Registered to the National Health System of the Republic of Cyprus (Gesy\n\nExclusion Criteria:\n\n1. Night Shift worker\n2. Fasting \\>12-h\u002Fday more than once a week or \\> once a week no food intake after 18:00\n3. Co-existing causes of chronic liver disease according to standard diagnostic testing including, but not restricted to:\n\n   1. Positive hepatitis B surface antigen\n   2. Positive hepatitis C virus RNA\n   3. Suspicion of drug-induced liver disease\n   4. Alcoholic liver disease\n   5. Autoimmune hepatitis\n   6. Wilson's disease\n   7. Hemochromatosis\n   8. Primary biliary cholangitis or primary sclerosing cholangitis\n   9. Known or suspected hepatocellular carcinoma\n4. Medications which cause liver disease or secondary hepatic steatosis (Tamoxifen, systemic corticosteroids, methotrexate, tetracycline, estrogens, valproic acid, and statin (registration is possible if statin is delivered in a consistent dosage within 12 weeks)\n5. Current or recent history (\\\u003C5 years) of significant alcohol intake (\\>30g of alcohol\u002F day or \\>210g\u002Fweek for men, \\>20g of alcohol\u002Fday or \\>140g\u002Fweek for women)\n6. Doctor diagnosed diabetes mellitus on insulin or sulfonylureas\n7. Severe medical comorbidities \\[ischemic heart disease, 3rd degree atrioventricular block, chronic obstructive pulmonary disease, severe hypertension (blood pressure \\>200\u002F120 mmHg)\\]\n8. Unstable weight (\\>5% change in the last 2 months) or participation in a weight-loss program within the past 12 weeks\n9. Sleep disorder (with a medical diagnosis) or individuals self-reporting sleep difficulties and poor sleep \\[average sleep less than 6 consecutive hours or patients who systematically experience sleep interruption for more than 2 times each night (waking up for toilet use is not to be considered sleep interruption)\\]\n10. Individuals with food allergies (or hypersensitivity to the fruits and vegetables that will be selected for the study)\n11. Systematic organic products consumers (defined as a self-reported usual consumption of more than 80% of their weekly fruits \\& vegetables being organic)\n12. Pregnant or trying to become pregnant or lactating women\n13. People not in position to communicate in Greek or English language\n14. Having metallic parts in the body.","70 Years",{"count":189,"type":21},[24],"The goal of this clinical trial is to study the effect of a time-restricted eating (TRE) dietary pattern combined with a time of consumption restriction about the daily portions of fruits and vegetables in people diagnosed with metabolic dysfunction-associated steatotic liver disease (MASLD).\n\nThe protocol of the study is an intention to treat protocol. The main research questions are:\n\n1. Does compliance in a TRE dietary scheme (positively) affect changes in body weight and body fat mass in people diagnosed with MASLD?\n2. Does an additional time restriction on the consumption of fruits and vegetables within the \"light-window\" of the day affects the metabolism of food contaminants?\n\nParticipants will be asked to:\n\n1. Adhere to a TRE dietary pattern for 3 months. TRE consists of an 8-hour eating vs 16 hours fasting within the day. First meal of the day should not occur at least an hour after wake-up time and last meal of the day should occur not later than 2 hours before bed-time.\n2. Adhere to a further time restricted consumption of a \"5-a-day\" portions of fruits and vegetables between the \"light-window hours\" between 9am to 4pm.\n3. Visit the Nutrition \\& Dietetics Clinic once every month for anthropometric measurements (on 4 time points).\n4. Collect and deliver first morning urine samples (on 7 time points).\n5. Collect and deliver saliva samples at baseline and at the end of the trial (Saliva collection should occur every 4-hours for 48-hours including fasting collection at baseline and at the end of three months)\n\n5\\) Complete a compliance and lifestyle questionnaire questionnaire via telephone interview to the research team every 2 weeks.\n\n6\\) Share photos to the research team with the use of an application on time of actual fruit and vegetables consumption, 3-4 times per week throughout the study protocol.\n\nResearchers will compare the designed intervention package of this TRE with the Standard of Care (SoC) protocol (based on the international guidelines) that is currently used in daily practice for the management of MASLD.",[112,374,28,375,242],"MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease","NAFLD - Non-Alcoholic Fatty Liver Disease",[377,378,379,380,381,382,112,383],"non alcoholic fatty liver disease (NAFLD)","chrononutrition","intermittent fasting","randomized controlled trial (RCT)","chronotoxicity","time restricted eating","Metabolic Dysfunction-Associated Steatotic Liver Disease","2025-11-18",{"date":386,"type":39},"2025-11-19",{"date":388,"type":21},"2026-01-05",{"date":390,"type":21},"2029-12-15",{"name":392,"class":46},"Cyprus University of Technology",{"id":394,"slug":4,"hasResults":11,"nctId":395,"briefTitle":396,"officialTitle":397,"acronym":398,"eligibilityCriteria":399,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":400,"targetDuration":4,"studyType":22,"phases":402,"briefSummary":403,"conditions":404,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":406,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":412,"locationsCount":72},"100581895","NCT06856252","Human Liver ORganoids as a Model to Study the Development of Non-Alcoholic SteatOhepatitis (NASH)","Human Liver ORganoids as a Model to Study the Role of the I148M Variant of the PNPLA3 Gene in the Development of Non-Alcoholic SteatOhepatitis (NASH)","REASON","Adult patients who have given consent to participate in the study and listed for the following procedures will be included:\n\n* liver biopsy for suspected non-alcoholic steatohepatitis (NASH) at the time of diagnosis;\n* liver resection for hepatocarcinoma or other liver lesions (including secondaries from other neoplasms and benign focal lesions, which will allow obtaining healthy starting liver tissue);\n* post-transplant healthy liver biopsies;\n* cholecystectomies.\n\nIt will also be required:\n\n* availability to sign informed consent for the study\n* availability of DNA sample for genetic analysis and clinical data,\n* blood sampling for genetic and epigenetic analyzes and analysis of non-coding RNAs (lncRNAs, miRNAs and circRNAs).\n\nPatients will be excluded who present:\n\n* positivity for chronic viral hepatitis (HCV-RNA and\u002For HBsAg);\n* positivity to other liver diseases such as autoimmune and viral hepatitis (hepatitis B and C), hereditary hemochromatosis, alpha-1-antitrypsin deficiency, Wilson's disease.",{"count":401,"type":21},60,[24],"The primary objective of the study is to generate and characterize three-dimensional models, called \"assembloids\", composed of the main liver cell populations (in particular from the co-culture of organoids with stellate cells, responsible for fibrogenesis, deriving from clinical samples). These models will be used in order to imitate the first phases of the onset of steatohepatitis, in conditions of altered lipid metabolism (induced through exposure to the main environmental determinants of this condition: excess fatty acids, fructose, cholesterol) in the presence or absence of the mutation I148M of PNPLA3. Other genetic variants will also be analyzed, such as TM6SF2, MBOAT7 and GCKR, which have previously been correlated with the development of non-alcoholic steatohepatitis.\n\nFurther objectives will be: 1) identify new biomarkers of pathological activation of human stellate cells and progression of liver damage, to be subsequently validated in clinical case series for future use in clinical management for individual risk stratification; 2) study the epigenetic factors that underlie the onset of non-alcoholic steatohepatitis and its progression to fibrosis, cirrhosis and HCC; 3) evaluate the impact of antisense oligonucleotides directed against PNPLA3 on the severity of the \"steatohepatitic\" phenotype (lipid accumulation, lipotoxicity and inflammation and fibrogenesis) in assembloids",[28],"2025-11-17",{"date":407,"type":39},"2025-11-20",{"date":409,"type":39},"2021-07-01",{"date":411,"type":21},"2032-07-31",{"name":297,"class":46},{"id":414,"slug":4,"hasResults":11,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":4,"eligibilityCriteria":418,"healthyVolunteers":15,"sex":16,"minAge":161,"maxAge":210,"enrollmentInfo":419,"targetDuration":4,"studyType":22,"phases":421,"briefSummary":422,"conditions":423,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":426,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":431,"locationsCount":72},"100559590","NCT06566105","The Liver BIoBank Lombardia of Fatty Liver","The Liver BIoBank Lombardia Genomic Cohort Study (LIVER-BIBLE): Personalized Medicine for the Management of Hepatic and Cardiovascular Thrombotic Complications of Fatty Liver","Inclusion Criteria:\n\n* Blood donors aged between 40 and 65 years presence of clinical diagnosis of overweight or obesity (body mass index-BMI \\> 25 kg\u002Fm2),\n* increased fasting blood glucose or T2D (fasting blood glucose ≥100mg\u002Fdl) or dyslipidemia (triglycerides≥150mg\u002Fdl, HDL\\\u003C45\u002F55 in M\u002FF) or arterial hypertension (n = 2,452, 11.8% of the entire cohort).\n\nExclusion Criteria:\n\n* subjects suffering from chronic degenerative diseases, except hypertension in good compensation and diabetes type 2 mellitus which does not require pharmacological therapy (as is already common practice for eligibility for donation of blood)\n* donors aged \\> 65 and \\\u003C 40 to avoid the introduction of bias",{"count":420,"type":21},2500,[24],"NAFLD is most frequently linked to excess adiposity, insulin resistance and cardiometabolic risk factors, it has become the leading cause of liver disease worldwide, and is associated with increased mortality due to multiple causes. HFC has a strong genetic component and the investigators recently showed that it plays a causal role in determining progressive liver disease and insulin resistance.\n\nThe genetic risk score predicting liver fat content (HFC-GRS) improves the stratification of liver related events, and the investigators have preliminary data on new common and rare variants that contribute to NAFLD susceptibility, and on a new non-invasive circulating biomarker associated with hepatic fat and lipotoxicity (Interleukin-32). However, no data are yet available on the causal role of hepatic fat on the procoagulant state associated with NAFLD, which could participate to liver damage and is a causal factor in atherothrombotic complications. The aim of the study is to examine the potential application of a precision medicine approach to the improvement of stratification of the risk of liver-related and cardiovascular thrombotic complications of hepatic fat accumulation (HFC) and non-alcoholic fatty liver disease (NAFLD), with a special focus on the role of procoagulant imbalance in mediating the at-risk phenotypes.",[28,424,425],"Precision Medicine","Cardiovascular Diseases",{"date":384,"type":39},{"date":428,"type":39},"2020-06-01",{"date":430,"type":21},"2037-12-31",{"name":297,"class":46},{"id":433,"slug":4,"hasResults":11,"nctId":434,"briefTitle":435,"officialTitle":435,"acronym":436,"eligibilityCriteria":437,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":305,"enrollmentInfo":438,"targetDuration":4,"studyType":22,"phases":440,"briefSummary":441,"conditions":442,"keywords":443,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":446,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":451,"locationsCount":454},"100414819","NCT04681573","Comparison of Two sTRAtegies For the Non-Invasive Diagnosis of advanCed Liver Fibrosis in NAFLD","TRAFIC","Inclusion Criteria:\n\n1. Presence of NAFLD as defined by :\n\n   * The presence of liver steatosis as assessed by ultrasonography (bright liver) or magnetic resonance imaging\u002Fspectroscopy (fat fraction \\>5.6%) or Controlled Attenuation Parameter (≥248 dB\u002Fm)\n   * The absence of steatosis-inducing drugs (systemic corticosteroids, methotrexate, amiodarone, tamoxifen)\n   * The absence of excessive alcohol consumption (\\\u003C210 g\u002Fweek in men or \\\u003C140 g\u002Fweek in women)\n   * The absence of other causes of chronic liver disease (chronic viral hepatitis B or C, hemochromatosis, auto-immune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, Wilson disease alpha-1-antitrypsin deficiency).\n2. Age ≥18 years and ≤80 years\n3. Affiliated person or beneficiary of a social security regime\n4. Written informed consent of the patient who agree to comply with the study protocol.\n\nExclusion Criteria:\n\n1. Decompensated cirrhosis (ascites, variceal bleeding, hepatic encephalopathy, liver failure, hepato-renal syndrome)\n2. Hepatocellular carcinoma\n3. Inability to safely undergo liver biopsy\n4. Participation in other intervention study with drug protocol treatment in progress at the time of inclusion or within one month prior to inclusion in the study.\n5. Pregnant, breastfeeding or parturient woman\n6. Person restricted by judicial or administrative decision\n7. Person under psychiatric care under restraint\n8. Person subject to a legal protection measure\n9. Person unable to express consent",{"count":439,"type":21},1045,[24],"NAFLD, closely linked to overweight and insulin resistance, has reached 25% prevalence worldwide. Advanced liver fibrosis(ALF) must be accurately diagnosed in NAFLD because it defines a subgroup of patients with impaired prognosis, and these patients need a specific management to prevent the occurrence of liver-related complication. Relatively few NAFLD patients develop ALF and it is a challenge for physicians to identify them.\n\nLiver biopsy is the reference for liver fibrosis evaluation but this invasive procedure cannot be first-line used in NAFLD. Non-invasive diagnosis of liver fibrosis is now available, especially liver stiffness measurement (LSM) with Fibroscan and blood fibrosis tests. However, Fibroscan is a costly device available only in few specialized centres with thus poor accessibility in face of the large NAFLD population. Blood fibrosis tests can be performed by every physician and are distinguished as \"complex\" or \"simple\". Because they include specialized biomarkers, complex blood fibrosis tests are accurate for the diagnosis of ALF but they are quite expensive and not reimbursed, with therefore limited use in clinical practice. Simple blood fibrosis tests have the advantage to include cheap and easy-to-obtain biomarkers with simple calculation thanks to free websites or smartphone applications. Simple blood fibrosis tests are globally less accurate than complex blood fibrosis tests or Fibroscan but, used with a high-sensitivity cut-off, they have the high interest of being able to accurately rule out advanced fibrosis in a significant proportion of NAFLD patients.\n\nRecently, two sequential diagnostic procedures have been developed for the diagnosis of ALF with the idea to combine the advantages of the different kind of fibrosis tests: the FIB4-Fibroscan (FIB4-FS) and the eLIFT-FibroMeterVCTE (eLIFT-FMVCTE) algorithms. These algorithms include as first-line procedure a simple blood fibrosis test (FIB4 or eLIFT) which identifies the patients who require a further second-line evaluation with a more accurate non-invasive test (Fibroscan or FibroMeterVCTE). Liver biopsy is finally used as third-line procedure in patients for whom the diagnosis remains undetermined. Such algorithms have the advantage to limit the use of complex fibrosis tests only to a subset of at risk-patients.\n\nThe TRAFIC study compare two strategies for the diagnosis of ALF in NAFLD patients: the FIB4-Fibroscan algorithm and the eLIFT-FibroMeterVCTE algorithm",[28],[444,28,445],"diagnosis","AdvanCed Liver Fibrosis",{"date":384,"type":39},{"date":448,"type":39},"2022-04-07",{"date":450,"type":21},"2028-12-07",{"name":452,"class":453},"University Hospital, Angers","OTHER_GOV",20,{"id":456,"slug":4,"hasResults":11,"nctId":457,"briefTitle":458,"officialTitle":459,"acronym":460,"eligibilityCriteria":461,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":462,"enrollmentInfo":463,"targetDuration":4,"studyType":22,"phases":464,"briefSummary":465,"conditions":466,"keywords":471,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":475,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":479,"locationsCount":72},"100562188","NCT06599918","Study of the Efficacy and Safety of Nicotinamide in Patients With Liver Fibrosis (NICOFIB)","Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Nicotinamide in Patients With and Liver Fibrosis (NICOFIB)","NICOFIB","Inclusion Criteria:\n\n* Patients aged between 18 and 85 years.\n* Diagnosis of non-alcoholic fatty liver disease (NAFLD) by their referring physicians (NAFLD defined as the presence of hepatic steatosis and in the absence of significant alcohol consumption, having excluded other liver diseases).\n* BMI between 27-40 kg\u002Fm2.\n* Fibroscan® value greater than 9.2 kPa, obtained within the last 6 months prior to the start of the study.\n\nExclusion Criteria:\n\n* Patients with any medical condition or illness that, in the opinion of the investigator, could interfere with the study results and\u002For affect the patients' ability to participate or complete the study.\n* History of clinically significant heart disease (ejection fraction \\\u003C40% \\[normal range 50-70%\\], heart failure defined as New York Heart Association \\[NYHA\\] Class \\> 2; clinically significant congenital or acquired valvular disease; symptomatic coronary artery disease such as myocardial infarction or angina, history of unstable arrhythmias, history of atrial fibrillation).\n* Decreased renal function (estimated glomerular filtration rate \\\u003C45 mL\u002Fmin\u002F1.73 m2, calculated using the CKD-EPI formula) at screening.\n* Alcohol consumption exceeding 30 g\u002Fday in men or 20 g\u002Fday in women.\n* Patients with significant impairment of liver function in the selection analysis defined as repeated values of AST, ALT, and bilirubin \\> 3 times the upper limit of normal.\n* Positive for hepatitis B surface antigen or hepatitis C antibodies.\n* Patients with hepatocellular carcinoma.\n* Patients with liver cirrhosis (Fibroscan® \\> 18, compatible biopsy, or those who have experienced decompensations of cirrhosis).\n* Patients diagnosed with human immunodeficiency virus (HIV).\n* Patients with hypersensitivity or a history of severe allergies to NAM or excipients used in the preparation of capsules (NAM and placebo).\n* Patients with iodinated contrast allergy.\n* History or evidence of an autoimmune disorder considered clinically significant by the investigator or requiring systemic, chronic use of systemic corticosteroids or other immunosuppressants.\n* Patients on treatment with hepatotoxic drugs (amiodarone, immunosuppressants, ART, antituberculosis drugs, corticosteroids, etc.).\n* Patients consuming narcotic and psychotropic substances with hepatotoxic effects.\n* Individuals with incapacitating diseases or cognitive impairment.\n* Institutionalized patients or those without a fixed address.\n* Principal investigator's discretion in case of indications of low adherence to the trial or follow-up visits.\n* Individuals with a life expectancy of less than 12 months.\n* Patients participating in another interventional clinical trial, excluding observational\u002Fnatural history studies, at the start of the study or within the last 30 days before the start of the study.\n* Previous use of vitamin B3 (NAM), with abstinence required for at least 3 months before screening.\n* Pregnant women as determined by a positive high-sensitivity serum or urine pregnancy test (minimum sensitivity of 25 IU\u002FL or equivalent units of hCG) within 24 hours prior to screening, dosing, or completion of the study. Women of childbearing potential (WOCBP) will undergo a pregnancy test (serum or urine) 24 hours prior to screening, dosing, or completion of the study. Such participants must use a highly effective contraceptive method, such as combined hormonal contraceptives or intrauterine device (IUD), in accordance with the Clinical Trial Facilitation Group, throughout the entire study.\n* Breastfeeding women.\n* Patients undergoing treatment\u002Fsupplementation with vitamin E.\n* Patients receiving probiotics.\n* Patients on the waiting list for bariatric surgery in the next 12 months.\n* Patients undergoing treatment with drugs that may have an effect on the progression of liver disease.\n* Drugs for the treatment of T2DM with effects on NAFLD (GLP-1 analogs, thiazolidinediones such as pioglitazone) initiated within 6 months before the study start.\n* Drugs for the treatment of T2DM with effects on intestinal microbiota (metformin, α-GI inhibitors, DPP-4 inhibitors, and SGLT-2 inhibitors) initiated within 6 months before the study start.\n* Patients who do not sign the informed consent.\n* Patients with contraindications to the contrast agent to be used in imaging tests.","85 Years",{"count":307,"type":21},[58],"The objective of this clinical trial, a pilot study, is to assess the impact of nicotinamide (NAM) on individuals with hepatic fibrosis.\n\nThe main question it aims to answer is:\n\n\\- To determine if the treatment with NAM is able to arrest, or even reduce, the hepatic fibrosis.\n\nIn addition, we also want to study the effect of NAM on:\n\n* General parameters (weight, HOMA-IR, etc).\n* Adiposity distribution (liver and body).\n* Systemic inflammation.\n* Thermogenic capacity of adipose tissue.\n* Microbiota composition.\n\nResearchers will compare NAM to a placebo, to see if NAM can arrest or revert hepatic fibrosis and its associated effects.\n\nParticipants will take either NAM or placebo. The dosage will be 1.2g\u002Fm2 NAM per day, for one year.",[467,264,468,28,469,470],"Fatty Liver","Hepatic Fibrosis","Nicotinamide","Overweight and Obese Adults",[469,472,473],"Fatty liver","Nafld","2025-11-14",{"date":384,"type":39},{"date":477,"type":39},"2024-04-23",{"date":202,"type":21},{"name":480,"class":46},"Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau",{"id":482,"slug":4,"hasResults":11,"nctId":483,"briefTitle":484,"officialTitle":485,"acronym":486,"eligibilityCriteria":487,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":488,"targetDuration":4,"studyType":22,"phases":490,"briefSummary":491,"conditions":492,"keywords":493,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":496,"lastUpdatePostDateStruct":497,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":502,"locationsCount":72},"100567722","NCT06671886","NAFLD Clinical Care Pathway","Testing the Effectiveness of NAFLD Clinical Care Pathway in VA Primary Care","NCCP","Inclusion Criteria:\n\nPatient Aligned Care Teams (PACT) at the Michael E. DeBakey VA Medical Center\n\nExclusion Criteria:\n\n* The investigators will exclude PACTs with unstable leadership (i.e., pending departure, vacancy) at time of randomization.\n* PACTs participating in the focus groups in Aim 1 will be excluded in Aim 2 to avoid cross contamination.\n* PACTs meeting the following criteria will be excluded from randomization in Aim 2:\n\n  * PACTs who do not treat NAFLD,\n  * PACTs not located at the main hospital,\n  * PACTs with less than 100 visits within 3 months.",{"count":489,"type":21},32,[24],"Non-alcoholic fatty liver disease (NAFLD) is a new condition that has become the most common chronic liver disease in the world and a main cause of liver cirrhosis, liver failure and liver cancer. Obesity and diabetes, conditions that are very common among Veterans are the main risk factors for NAFLD. Therefore, the burden of NAFLD and its complications among Veterans is substantial. However, most VA patients with NAFLD are undiagnosed and untreated, and their care is not consistent with practice guidelines. The NAFLD Clinical Care Pathway (NCCP) intervention seeks to close this major gap in the care of Veterans by automatically identifying patients at risk of NAFLD, calculating their risk scores of having severe NAFLD, and educating the primary care providers on the diagnosis and treatment of NAFLD. This clinical trial will test the benefit of this NCCP intervention against usual care in increasing the rates of NAFLD diagnosis as well as referral to and enrollment in appropriate treatment. The study will also identify barriers and promotors of future NCCP implementation.",[28,112],[28,494,495,112],"Veterans","Primary health care","2025-11-13",{"date":474,"type":39},{"date":499,"type":39},"2024-02-02",{"date":501,"type":21},"2028-11-13",{"name":503,"class":504},"VA Office of Research and Development","FED",{"id":506,"slug":4,"hasResults":11,"nctId":507,"briefTitle":508,"officialTitle":508,"acronym":509,"eligibilityCriteria":510,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":511,"enrollmentInfo":512,"targetDuration":4,"studyType":22,"phases":514,"briefSummary":515,"conditions":516,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":517,"lastUpdatePostDateStruct":518,"startDateStruct":520,"completionDateStruct":522,"leadSponsor":524,"locationsCount":72},"100438330","NCT04987879","NASH AMPK Exercise Dosing (AMPED) Trial","AMPED","Inclusion Criteria:\n\n* Age 18-69 years\n* Sedentary \\[\\\u003C90 min\u002Fwk of exercise identified by the Get Active Questionnaire (GAQ)\n* BMI \\>25kg\u002Fm2\n* Liver biopsy within six months prior to enrollment showing:\n\n  * NASH defined by NASH Clinical Research Network (CRN) histology scoring system (NAS) \\>4 and MRI-PDFF \\>5% and;\n  * Liver fibrosis stage 1-3\n\nExclusion Criteria:\n\n* Active cardiac symptoms\n* Body mass index (BMI) \\>45kg\u002Fm2\n* Cancer that is active\n* Inability to walk \\>2 blocks\n* Institutionalized\u002Fprisoner\n* Other liver disease\n* Pregnancy\n* Secondary hepatic steatosis\n* Severe comorbidities\n* AUDIT-C questionnaire identified significant alcohol use\n* Substance abuse\u002Factive smoking\n* Uncontrolled diabetes (changes in drug dosing over previous three months or A1c \\>9%)\n* GAQ response indicates exercise may be unsafe.","69 Years",{"count":513,"type":21},45,[24],"There is no known cure or regulatory agency approved drug therapy for nonalcoholic fatty liver disease (NAFLD), the leading cause of liver disease worldwide, and its progressive type, NASH. This places increased importance on using exercise to treat NAFLD.\n\nWhile physical activity is recommended for all with NAFLD, how to best prescribe exercise as a specific treatment remains unknown, including what dose of exercise is most effective.",[28],"2025-10-10",{"date":519,"type":39},"2025-10-14",{"date":521,"type":39},"2022-08-30",{"date":523,"type":21},"2026-07-15",{"name":525,"class":46},"Milton S. Hershey Medical Center",{"id":527,"slug":4,"hasResults":11,"nctId":528,"briefTitle":529,"officialTitle":530,"acronym":4,"eligibilityCriteria":531,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":369,"enrollmentInfo":532,"targetDuration":4,"studyType":22,"phases":534,"briefSummary":536,"conditions":537,"keywords":4,"overallStatus":222,"whyStopped":4,"lastUpdateSubmitDate":539,"lastUpdatePostDateStruct":540,"startDateStruct":542,"completionDateStruct":544,"leadSponsor":546,"locationsCount":4},"100608204","NCT07198516","The Improvement Effect of Henggliejin on Fatty Liver in Type 2 Diabetes Patients With Nonalcoholic Fatty Liver:","The Improvement Effect of Henggliejin on Fatty Liver in Type 2 Diabetes Patients With Nonalcoholic Fatty Liver: a Multicenter, Prospective, Single Arm Clinical Study","Inclusion Criteria:\n\n* (1) Type 2 diabetes diagnosed according to WHO diagnostic criteria, age ≥ 18 years old, ≤ 70 years old, gender unlimited (2) Diagnosed with NAFLD according to the criteria of the \"Guidelines for the Prevention and Treatment of Non alcoholic Fatty Liver Disease (2018 Updated Edition)\" (3) Before screening, patients with type 2 diabetes who were treated with single or combined drugs of stable dose (except TZDs, SGLT2i, GLP-1RA, insulin and GKAs) for ≥ 8 weeks and had poor blood glucose control, 7% ≤ HbA1c ≤ 10% (4)BMI≥24 kg\u002Fm2 (5) Can understand the content and methods of this study and voluntarily sign an informed consent form\n\nExclusion Criteria:\n\n* (1) Patients with diabetes other than type 2 diabetes, including type 1 diabetes and gestational diabetes (2) Acute diabetes complications such as diabetes ketosis or ketoacidosis, diabetes hypertonic state, diabetes lactic acidosis or serious chronic diabetes complications (3) Individuals with a history of recurrent urinary tract infections and\u002For genital infections (as determined by clinical physicians) (4) Alcoholic liver disease (alcohol consumption equivalent to less than 30 g\u002Fd for males and less than 20 g\u002Fd for females in the past two years) (5) Exclude other liver diseases, such as chronic hepatitis B, chronic hepatitis C, primary cholestatic cirrhosis, ballistic obstructive diseases, drug-induced liver damage, hemochromatosis, hepatolenticular deformation, autoimmune hepatitis (6) Combined cirrhosis, combined liver cancer, HIV positive, drug abuse (7) Drugs (tamoxifen, amiodarone, sodium valproate, methotrexate, glucocorticoid, etc.), total parenteral nutrition, inflammatory bowel disease, celiac disease, hypothyroidism, Cushing's syndrome, β - lipoprotein deficiency, lipoatrophic diabetes, Mauriac syndrome, and other special conditions leading to fatty liver (8) Serious trauma or acute infection that may affect blood glucose control occurred within 4 weeks (9) Individuals who have experienced decompensated heart failure (NYHA grades III and IV), unstable angina, stroke or transient ischemic attack, myocardial infarction, severe arrhythmia, or have undergone cardiac surgery or vascular reconstruction (including coronary artery bypass grafting or percutaneous coronary intervention) within 6 months (10) There are obvious blood system diseases (such as aplastic anemia, myelodysplastic syndrome) or any diseases that cause hemolysis or red blood cell instability (such as malaria, hemolytic anemia) (11) Individuals with severe chronic gastrointestinal diseases, or those who have received treatment that may affect drug absorption (such as gastrointestinal surgery) (12) Uncontrolled hyperthyroidism (13) Individuals with mental or neurological disorders who are unwilling to communicate or unable to fully understand and collaborate (14) Pregnant or lactating women (15) There are any laboratory test indicators that meet the following standards:\n\n  1. Alanine aminotransferase\\>2.0 times ULN and\u002For aspartate aminotransferase\\>2.0 times ULN and\u002For total bilirubin\\>2.0 times ULN\n  2. Blood ketones\\>ULN\n  3. eGFR \\\u003C30ml\u002Fmin\u002F1.73 m2； Note: The formula for calculating eGFR is CKD-EPI (which can be calculated within the WeChat mini program)\n  4. Blood creatine kinase\\>3 times ULN (16) In addition to the above, the researchers have determined that patients who are not suitable to participate in this clinical trial",{"count":533,"type":21},149,[535],"EARLY_PHASE1","To evaluate the effect and safety of Henggliejin on fatty liver in type 2 diabetes patients with nonalcoholic fatty liver disease",[28,538],"Diabete Type 2","2025-09-29",{"date":541,"type":39},"2025-09-30",{"date":543,"type":21},"2025-11-01",{"date":545,"type":21},"2026-12-31",{"name":547,"class":46},"Fujian Medical University Union Hospital",{"id":549,"slug":4,"hasResults":11,"nctId":550,"briefTitle":551,"officialTitle":551,"acronym":552,"eligibilityCriteria":553,"healthyVolunteers":11,"sex":16,"minAge":554,"maxAge":17,"enrollmentInfo":555,"targetDuration":4,"studyType":22,"phases":557,"briefSummary":559,"conditions":560,"keywords":563,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":565,"lastUpdatePostDateStruct":566,"startDateStruct":568,"completionDateStruct":570,"leadSponsor":572,"locationsCount":72},"100511160","NCT05935826","Effect of Amino Acids on Hepatic Fat Content in Adolescents (AMINOS Study)","AMINOS","Inclusion Criteria\n\n* Ages 13-18, Tanner stage 4-5\n* Suspected or diagnosed with NAFLD per fibroscan or liver biopsy within 6 months prior to enrollment as long as participants have not lost more than 5% of total body weight. Their MRI liver fat \\>5.5%\n* Diagnosis of non-alcoholic fatty liver disease (NAFLD) per hepatologist\n* Sedentary- less than 3 hours of moderate (jogging, swimming, etc.) exercise a week\n* BMI equal or greater than the 85th percentile for age and gender, this is overweight and obese categories\n\nExclusion Criteria\n\n* Use of medications known to affect insulin sensitivity: metformin, oral glucocorticoids within 10 days, atypical antipsychotics, immunosuppressant agents, HIV medications.\n* Currently pregnant or breastfeeding women. Development of pregnancy during the study period will necessitate withdrawal from the study\n* Severe illness requiring hospitalization within 60 days\n* Diabetes, defined as Hemoglobin A1C \\> 6.4%\n* BMI percentile less than the 85th percentile for age and sex. Waist circumference \\>200 cm\n* Anemia, defined as Hemoglobin \\\u003C 11 mg\u002FdL\n* Diagnosed major psychiatric or developmental disorder limiting informed consent\n* Implanted metal devices that are not compatible with MRI\n* Use of blood pressure medications\n* Known liver disease other than NAFLD or AST or ALT \\>150 IU\u002FL","13 Years",{"count":556,"type":21},55,[558],"PHASE3","Participants 13-18 years of age with extra fat stored in the liver will be randomly assigned to a protein supplement or placebo \"fake supplement\" for 2 months to see if the participants who get the protein supplement have less fat in the liver compared to participants who were in the placebo group. After the 2 month intervention, all participants can continue the study and will all receive the protein supplement for an additional 10-months.",[561,28,562],"Hepatic Steatosis","Adolescent Obesity",[564],"Amino Acid Supplement","2025-08-21",{"date":567,"type":39},"2025-08-28",{"date":569,"type":39},"2024-06-18",{"date":571,"type":21},"2026-08-31",{"name":573,"class":46},"University of Colorado, Denver",{"id":575,"slug":4,"hasResults":11,"nctId":576,"briefTitle":577,"officialTitle":577,"acronym":578,"eligibilityCriteria":579,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":305,"enrollmentInfo":580,"targetDuration":4,"studyType":22,"phases":581,"briefSummary":582,"conditions":583,"keywords":587,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":598,"lastUpdatePostDateStruct":599,"startDateStruct":601,"completionDateStruct":603,"leadSponsor":605,"locationsCount":608},"100566936","NCT06661655","Evaluation of a New Ultrasound System for the Non-invasive Assessment of Liver Steatosis in MASLD\u002FMASH Patients","ACOUSTIQ","Inclusion Criteria:\n\n* Adult patient below 80 yo\n* Patients with MASLD\u002FMASH recruited in interventional trials requiring MRI PDFF +\u002F- MRE per interventional protocol, OR\n* Patients with MASLD\u002FMASH recruited in prospective cohorts requiring MRI PDFF +\u002F- MRE per interventional protocol, OR\n* Patients referred to MRI-PDFF or MRE.\n* Patients who consented in written to participate in the study\n* Patients with ongoing social security coverage\n\nExclusion Criteria:\n\n* Patient in their minority (less than 18 yo) or older than 80 yo,\n* Patient with active implants,\n* Patient presenting with a wound where the Hepatoscope exam shall be performed (abdominal right upper quadrant)\n* Patient with a history of decompensated cirrhosis,\n* Patient with a history of hepatocellular carcinoma,\n* Adult patient under tutorship, or unable to express informed consent,\n* Pregnant or breast-feeding\n* Person deprived from their liberty\n* Patient hospitalized without providing consent or in case of an emergency\n* Patient presenting with another know liver disease",{"count":350,"type":21},[24],"The objective of the study is to evaluate an ultraportable ultrasound device, Hepatoscope, for the non-invasive assessment of hepatic steatosis in patients with metabolic-dysfunction associated liver diseases (MASLD), by comparing its measurements with current diagnostic modalities, such as MRI-PDFF.",[584,467,109,112,585,586,28],"Metabolic Syndrome X","NASH (Non-Alcoholic Steatohepatitis)","Steatosis, Liver",[588,589,590,591,592,593,594,595,596,597],"Liver","Fibrosis","Steatosis","Elastography","Ultrasound","Attenuation","Backscattering coefficient","Sound speed","MRI PDFF","Hepatoscope","2025-08-12",{"date":600,"type":39},"2025-08-15",{"date":602,"type":39},"2025-07-24",{"date":604,"type":21},"2026-09-01",{"name":606,"class":607},"E-Scopics","INDUSTRY",3,{"id":610,"slug":4,"hasResults":11,"nctId":611,"briefTitle":612,"officialTitle":613,"acronym":4,"eligibilityCriteria":614,"healthyVolunteers":15,"sex":16,"minAge":615,"maxAge":258,"enrollmentInfo":616,"targetDuration":4,"studyType":22,"phases":617,"briefSummary":618,"conditions":619,"keywords":624,"overallStatus":222,"whyStopped":4,"lastUpdateSubmitDate":630,"lastUpdatePostDateStruct":631,"startDateStruct":633,"completionDateStruct":635,"leadSponsor":637,"locationsCount":72},"100280677","NCT02933554","Bariatric Embolization of Arteries for the Treatment of Nonalcoholic Steatohepatitis","A Single Center, Non-randomized Study to Evaluate the Safety and Efficacy of Left Gastric Artery Embolization, to Promote Short-term Weight Loss in Obese Patients With Nonalcoholic Steatohepatitis (NASH) and Thereby Improve NASH","Inclusion Criteria:\n\n1. Male or Female, aged 22 years or older.\n2. Willing, able and mentally competent to provide written informed consent and willing to comply with all study procedures and be available for the duration of the study\n3. BMI \\>35 kg\u002Fm2\n4. Adequate hematological, hepatic and renal function as follows:\n\n   1. Hematological: Hematological: If the bariatric embolization procedure is being performed by femoral access: platelets \\> 50 x 109\u002FL, INR \\\u003C1.5. If the bariatric embolization procedure is being performed by radial access: platelets \\>35 x 109\u002FL and INR \\\u003C1.5 OR platelets \\>50 x 109\u002FL and INR between 1.5 and 2.\"\n   2. Hepatic : Total bilirubin \\\u003C3 mg\u002FdL\n   3. Renal: Estimated GFR \\> 60ml\u002Fmin.1.73m2\n5. If Center for Epidemiological Studies Depression (CESD) score \\> or =16 AND is in care of behavior health specialist who has indicated patient has adequate coping mechanisms to undergo procedure and does not foresee mental health as barrier to participation in study.\n6. Elevated alanine or aspartate aminotransferase values (ALT \\>41 or AST\\>34 U\u002FL).\n7. Liver biopsy showing evidence of NASH in the past 12 months.\n8. No evidence of another form of liver disease.\n9. Patients diagnosed with NASH and have evidence of failing other methods of weight loss through diet, exercise and behavior modification.\n\nExclusion Criteria:\n\n1. Pregnancy\n2. Active substance abuse\n3. Significant psychiatric problems, severe enough to cause suffering or a poor ability to function in life. Center for Epidemiological Studies Depression (CESD) score \\> or = 16 without psychiatric evaluation. \\[If Center for Epidemiological Studies Depression (CESD) score \\> or =16 AND is in care of behavior health specialist who has indicated patient has adequate coping mechanisms to undergo procedure and does not foresee mental health as barrier to participation in study.\\]\n4. Significant alcohol consumption ( \\>20 g\u002Fday in women, \\>30 g\u002Fday in men)\n5. Weight \\> 400 lbs, BMI \\> 50 kg\u002Fm2.\n6. Contraindications to obtaining a liver biopsy\n7. Subjects with pre-existing abdominal pain will be excluded (because of the potential confusion with pain related to the procedure).\n8. Subjects who are intolerant to PPIs\n9. Subjects requiring any anticoagulant medications should be excluded if radial access cannot be obtained.\n10. Subjects with platelets \\\u003C35 x 109\u002FL and INR \\> 2.0\n11. Subjects who are taking aspirin\u002F NSAIDs and in whom these medications are unable to be withdrawn from aspirin and NSAIDs for at least 3 days prior to the LGAE procedure and for 30 days following the LGAE procedure (because of the potential risks of gastric bleeding following the procedure).\n12. Presence of systemic illness or other medical conditions relevant to survival .(Note that in the HCC pre liver transplant cohort, the presence of HCC will not be considered an exclusion criteria)\n13. Metastatic cancer\n14. Evidence of decompensated liver disease (uncontrolled ascites, or uncontrolled spontaneous encephalopathy)\n15. prior surgical weight loss procedures including gastroplasty, jejunoileal, or jejunocolic bypass, total parenteral nutrition within the past 6 months; Prior history of gastric pancreatic, hepatic, and\u002For splenic surgery\n16. Prior embolization to the stomach, spleen or liver, unless the prior embolization was a transarterial chemoembolization (TACE) to the liver for HCC.\n17. If review of available prior imaging studies (i.e CT, MRI, or US)shows potential anatomical variations, presence of severe atheromatous disease, large arteriovenous shunting of blood.\n18. Abnormal Endoscopy - large sliding hiatal hernia or paraesophageal hernia, active peptic ulcer disease, active H. pylori infection\n19. History of abnormal Nuclear Gastric Motility examination-defined as delayed emptying of gastric contents \\> 90%, 60% and 10% at 1 hour, 2 hours, and 4 hours respectively.\n20. ASA Class 4 or 5\n21. Child Pugh classification C\n22. Known aortic disease, such as dissection or aneurysm; peripheral arterial disease or other cardiovascular disease.\n23. Type 2 diabetes on anti-diabetic medications that are known to cause hypoglycemia. e.g. sulphonylureas, meglitinides\n24. Patients with a known other cause for their increased liver enzyme levels such as viral hepatitis (B or C), autoimmune\u002Fchronic immune hepatitis, primary biliary cholangitis, metabolic and genetic hemochromatosis, Wilson's disease, or alpha-1 antitrypsin deficiency\n25. Patient taking hepatotoxic drugs. List of drugs causing steatohepatitis include but are not limited to: amiodarone, chemotherapy (5-fluorouracil, tamoxifen, irinotecan, cisplatin, and asparaginase), glucocorticoids, methotrexate, sulfonamides, antithyroid drugs, phenytoin, tetracyclines, isoniazid, salicylates, and valproic acid.\n26. Contraindications to obtaining a liver biopsy (NASH cohort)\n27. Patients taking other trial medications for NASH.","22 Years",{"count":163,"type":21},[24],"Obesity is an epidemic in the US. With progression of obesity, Nonalcoholic steatohepatitis (NASH) has been a growing public health issue. Presently there is no cure for NASH.Prevention of progression of fibrosis in NASH is crucial, as they are at a high risk for cirrhosis and may need liver transplant.\n\nRecent studies have shown that blocking blood vessels to a particular portion of the stomach (bariatric or left gastric artery embolization) can temporarily decrease levels of the appetite inducing hormone ghrelin, and result in weight loss.The purpose of this study is to determine if Left gastric artery embolization (LGAE) in patients with obesity and NASH leads to clinically significant weight loss with improvement of NASH.",[264,620,621,622,623,28],"Weight Loss","Body Weight","Nonalcoholic Steatohepatitis","Nonalcoholic Fatty Liver Disease",[625,626,627,108,628,629],"bariatric surgery","minimally invasive","Embolization","ghrelin","gastric artery embolization","2025-07-23",{"date":632,"type":39},"2025-07-28",{"date":634,"type":21},"2025-12",{"date":636,"type":21},"2027-06",{"name":638,"class":46},"Keith Pereira, MD:",""]