[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100530967":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":18,"studyPopulation":18,"armGroups":27,"interventions":39,"overallOfficials":47,"centralContacts":51,"locations":63,"responsibleParty":86,"collaborators":88,"id":91,"slug":18,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":98,"sex":99,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":18,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":18,"overallStatus":66,"whyStopped":18,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"German Diabetes Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Whole-body insulin sensitivity and WAT insulin sensitivity","Hyperinsulinemica-euglycemia clamp tests with deuterated glucose to measure fasting and insulin-stimulated whole-body insulin sensitivity and measurement of the index ADIPO-IR (fasting insulin x free fatty acid concentration) before and after dietary intervention period.","3 weeks intervention period each",[14],{"measure":15,"description":16,"timeFrame":17},"WAT insulin signaling pathways","Adipose tissue biopsies are planned to be taken during the fasting and insulin-stimulated state before and after the dietary intervention period. DAG and ceramide subcellular fractionation assay is planned to be performed. Expressionanalyses for activation \u002Fmembrane translocation of novel and atypical protein kinase C isoforms will be done. Determination of the degree of phosphorylation of various components of the insulin pathway via Western blot are planned.","3 weeks intervention time",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":18,"primaryPurpose":22,"observationalModel":18,"timePerspective":18,"maskingInfo":23},"RANDOMIZED","PARALLEL","BASIC_SCIENCE",{"masking":24,"maskingDescription":18,"whoMasked":25},"SINGLE",[26],"INVESTIGATOR",[28,34],{"label":29,"type":30,"description":31,"interventionNames":32},"High-fat overnutrition","ACTIVE_COMPARATOR","Lipid overnutrition: 40% higher lipid consumption per day than required over three weeks.",[33],"Behavioral: High-fat overnutrition",{"label":35,"type":30,"description":36,"interventionNames":37},"Normocaloric macronutrient-balanced nutrition","Normocaloric, macronutrient-balanced nutrition per day over three weeks",[38],"Behavioral: Normocaloric macronutrient-balanced nutrition",[40,44],{"type":41,"name":29,"description":42,"armGroupLabels":43,"otherNames":18},"BEHAVIORAL","Overnutrition: 40% higher lipid consumption per day than required",[29],{"type":41,"name":35,"description":45,"armGroupLabels":46,"otherNames":18},"Normocaloric, macronutrient-balanced nutrition:\n\nCalories requirement for weight maintenance \\[(kcal\u002Fd) 55% carbohydrates, 15% proteins, 30% fat\\]",[35],[48],{"name":49,"affiliation":5,"role":50},"Michael Roden, Prof., MD","STUDY_DIRECTOR",[52,58],{"name":53,"role":54,"phone":55,"phoneExt":56,"email":57},"Theresia Sarabhai, MD","CONTACT","0173-9473478","DDZ","theresia.sarabhai@ddz.de",{"name":59,"role":54,"phone":60,"phoneExt":61,"email":62},"Sabine Kahl, MD","0221-3382-","698","sabine.kahl@ddz.de",[64],{"facility":65,"status":66,"city":67,"state":68,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":78},"Georgia Xourafa","RECRUITING","Düsseldorf","North Rhine-Westphalia","40225","Germany","DE",{"type":73,"coordinates":74},"Point",[75,76],6.77927,51.22319,{"lat":76,"lon":75},[79,83],{"name":80,"role":54,"phone":81,"phoneExt":18,"email":82},"Georgia Xourafa, MD","+492113382426","georgia.xourafa@ddz.de",{"name":53,"role":54,"phone":84,"phoneExt":18,"email":85},"0211-3382-0","theresia.Sarabhai@ddz.de",{"type":87,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[89],{"name":90,"class":6},"Yale University","100530967",false,"NCT06193668","Overfeeding Induced Fat-tissue Stimulation","Short-term High-fat Overnutrition Induces Insulin Resistance in White Adipose Tissue","OVID_FASTI","Inclusion Criteria:\n\n* Age between 18 and 40 years\n* BMI \\\u003C 29 kg\u002Fm2\n* Sport inactive (\\\u003C1x \u002Fweek)\n* Capacity to consent\n\nExclusion Criteria:\n\n* Diabetes mellitus disease\n* Acute coronary heart syndrome (myocardial infarction, unstable angina pectoris, stroke or transient ischemic attack in the last 3 months before study participation)\n* Acute infectious disease\n* Taking blood glucose-lowering drugs\n* Diseases or drugs affecting the immune system and allergies to drugs used in the study\n* Drugs with potential metabolic effects\n* Chronic liver disease (hepatitis, gallbladder disease, elevated liver enzymes (ALT \\> 300 U\u002FL))\n* Chronic inflammatory bowel diseases\n* Rheumatic diseases\n* Hyper- or hypothyroidism of the thyroid gland\n* Renal insufficiency, administration of iodine-containing contrast media in the last 2 days\n* Chronic lung diseases\n* cancerous diseases\n* Addictive diseases, psychiatric diseases\n* Pregnancy, breastfeeding\n* Shift workers\n* Anemia (Hb \\\u003C12 g\u002Fdl)\n* Disorders of hemostasis\n* Regular use of antithrombotic drugs\n* Alcohol consumption, smoking\n* Conditions that do not permit an MRI examination",true,"ALL","18 Years","40 Years",{"count":103,"type":104},32,"ESTIMATED","INTERVENTIONAL",[107],"NA","Type 2 diabetes is the most common metabolic disease worldwide, characterized by hyperglycemia, decreased whole body insulin sensitivity, and white adipose tissue (WAT) dysfunction. A key factor in its development is chronic overnutrition, usually with a high-fat diet (HFD), leading to disturbances of glucose and lipid metabolism. However, the mechanism of short-term HFD-induced tissue-specific insulin resistance remains poorly understood. This project aims to further unravel the underlying mechanisms of short-term HFD overnutrition-mediated WAT insulin resistance. The model described here corresponds to a randomized, single- blinded parallel-grouped trial, consisting of two interventions: a macronutrient-balanced diet and or a hypercaloric diet over three weeks in order to investigate differences in interorgan fatty acid and glucose metabolism between the studied groups. Based on recent studies, the hypothesis is that 21-day hypercaloric HFD induces WAT insulin resistance via a diacylglycerol, novel protein kinase C-insulin receptor signaling model in both fasting and insulin-stimulated states.",[110],"Lipid-induced Insulin Resistance","2024-02-29",{"date":113,"type":114},"2024-03-01","ACTUAL",{"date":116,"type":114},"2024-01-31",{"date":118,"type":104},"2030-12-31",{"name":5,"class":6},1]