[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600891":3},{"organization":4,"outcomesModule":7,"designInfo":88,"detailedDescription":16,"studyPopulation":16,"armGroups":97,"interventions":110,"overallOfficials":16,"centralContacts":16,"locations":118,"responsibleParty":139,"collaborators":16,"id":143,"slug":16,"hasResults":144,"nctId":145,"briefTitle":146,"officialTitle":146,"acronym":16,"eligibilityCriteria":147,"healthyVolunteers":144,"sex":148,"minAge":149,"maxAge":150,"enrollmentInfo":151,"targetDuration":16,"studyType":154,"phases":155,"briefSummary":157,"conditions":158,"keywords":160,"overallStatus":121,"whyStopped":16,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":174},{"fullName":5,"class":6},"Second Xiangya Hospital of Central South University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"BMI (Body Mass Index)","BMI used to assess body weight relative to height, the unit of BMI is kg\u002Fm² (kilograms per square meter).","\"Baseline\" \"6 weeks\" and \"12 weeks\"",[14,17,19,21,23,27,30,33,35,37,39,41,43,46,49,52,54,56,60,62,64,66,68,70,72,75,78,80,82,84],{"measure":15,"description":16,"timeFrame":12},"Weight",null,{"measure":18,"description":16,"timeFrame":12},"Waist circumference",{"measure":20,"description":16,"timeFrame":12},"Hip circumference",{"measure":22,"description":16,"timeFrame":12},"Waist-to-hip ratio",{"measure":24,"description":25,"timeFrame":26},"Human body fat percentage","It measured via Lunar iDXA equipment","\"Baseline\" and \"12 weeks\"",{"measure":28,"description":29,"timeFrame":26},"Human basal metabolic rate","It measured via Lunar iDXA equipment, including basal metabolic rate, body fat percentage, visceral fat area, subcutaneous fat area, etc.)",{"measure":31,"description":32,"timeFrame":26},"Visceral fat mass","It measured via iDXA equipment",{"measure":34,"description":32,"timeFrame":26},"Subcutaneous fat area",{"measure":36,"description":16,"timeFrame":12},"Serum triglycerides",{"measure":38,"description":16,"timeFrame":12},"Serum total cholesterol",{"measure":40,"description":16,"timeFrame":12},"Serum LDL-c",{"measure":42,"description":16,"timeFrame":12},"Serum HDL-c",{"measure":44,"description":45,"timeFrame":26},"Gut microbiome","including fecal intestinal flora metagenome",{"measure":47,"description":48,"timeFrame":26},"Gut metabolites","In aid of LC\u002FMS and GC\u002FMS technique, etc, we will measure the metabolomics molecular profile in fecal samples before and after treatment.The metabolomics measurement will help to detect the profile of all kinds of lipids species and amino acid species, etc.",{"measure":50,"description":51,"timeFrame":26},"Serum metabolites","In aid of LC\u002FMS and GC\u002FMS technique, etc, we will measure the metabolomics molecular profile in blood samples before and after treatment.The metabolomics measurement will help to detect the profile of all kinds of lipids species and amino acid species, etc.",{"measure":53,"description":16,"timeFrame":12},"Fasting serum C peptide levels",{"measure":55,"description":16,"timeFrame":12},"Fasting serum insulin levels",{"measure":57,"description":58,"timeFrame":59},"Fasting blood glucose","It applies to individuals with overweight or obese type 2 diabetes","\"Baseline\" \"6 weeks\" \"12 weeks\"",{"measure":61,"description":58,"timeFrame":12},"Glycated albumin",{"measure":63,"description":58,"timeFrame":12},"Glycated haemoglobin (HbA1c)",{"measure":65,"description":16,"timeFrame":26},"2-hour serum C peptide levels",{"measure":67,"description":16,"timeFrame":26},"2-hour serum insulin levels",{"measure":69,"description":16,"timeFrame":26},"2-hour blood glucose levels",{"measure":71,"description":16,"timeFrame":12},"HOMA-IR (Homeostatic Model Assessment of Insulin Resistance)",{"measure":73,"description":74,"timeFrame":12},"Inflammation markers","CRP, IgG, IgA, IgM, IgE",{"measure":76,"description":77,"timeFrame":12},"Hepatic function","including alanine aminotransferase and aspartate aminotransferase",{"measure":79,"description":16,"timeFrame":12},"Serum urea nitrogen",{"measure":81,"description":16,"timeFrame":12},"Serum creatinine",{"measure":83,"description":16,"timeFrame":12},"Serum urinary acid",{"measure":85,"description":86,"timeFrame":87},"Adverse events","Safety outcomes","12 weeks",{"allocation":89,"interventionModel":90,"interventionModelDescription":16,"primaryPurpose":91,"observationalModel":16,"timePerspective":16,"maskingInfo":92},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":93,"maskingDescription":16,"whoMasked":94},"DOUBLE",[95,96],"PARTICIPANT","INVESTIGATOR",[98,104],{"label":99,"type":100,"description":101,"interventionNames":102},"Attapulgite","EXPERIMENTAL","Attapulgite capsules (0.4-0.5 g) were administered at a dose of 3 capsules twice daily for 12 weeks.",[103],"Dietary Supplement: Attapulgite",{"label":105,"type":106,"description":107,"interventionNames":108},"Placebo","PLACEBO_COMPARATOR","Maltodextrin capsules (0.4-0.5 g) were administered at a dose of 3 capsules twice daily for 12 weeks.",[109],"Dietary Supplement: Placebo",[111,115],{"type":112,"name":99,"description":113,"armGroupLabels":114,"otherNames":16},"DIETARY_SUPPLEMENT","Participants were administered daily attapulgite (2.5 g) for a duration of 12 weeks.",[99],{"type":112,"name":105,"description":116,"armGroupLabels":117,"otherNames":16},"Participants were administered daily maltodextrin (2.5 g) for a duration of 12 weeks.",[105],[119],{"facility":120,"status":121,"city":122,"state":123,"zip":124,"country":125,"countryCode":126,"cosmosGeoPoint":127,"geoPoint":132,"contacts":133},"Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University","RECRUITING","Changsha","Hunan","410011","China","CN",{"type":128,"coordinates":129},"Point",[130,131],112.97087,28.19874,{"lat":131,"lon":130},[134],{"name":135,"role":136,"phone":137,"phoneExt":16,"email":138},"Yang Xiao, MD\u002FPhD","CONTACT","86-0731-85292154","xiaoyang29@csu.edu.cn",{"type":140,"investigatorFullName":141,"investigatorTitle":142,"investigatorAffiliation":5,"oldNameTitle":16,"oldOrganization":16},"PRINCIPAL_INVESTIGATOR","Yang Xiao","Associate Professor, Department of Metabolism and Endocrinology, Institute of Metabolism and Endocrinology, National Clinical Research Center for Metabolic Diseases, Second Xiangya Hospital, Central South University","100600891",false,"NCT07103382","Efficacy and Safety of Attapulgite in Patients With Obesity: An Exploratory Clinical Trial","Inclusion Criteria:\n\nObese individuals:\n\n* Aged 18-60 years, regardless of sex\u002Fgender\n* BMI≥28.0kg\u002Fm2\n\nOverweight or obese individuals with type 2 diabetes:\n\n* Aged 18-60 years, regardless of sex\u002Fgender\n* BMI≥24.0kg\u002Fm2\n* HbA1c ≥7.0% and ≤10.0% or the fasting blood glucose ≥7.0 mmol\u002Fl and ≤ 13.3 mmol\u002Fl at screening\n* Stable diabetes treatment for at least 6 months or more\n\nExclusion Criteria:\n\n* Type 1 diabetes, monogenic diabetes, or diabetes due to pancreatic injury or other secondary diabetes\n* Severe diabetic complications within three months before the study initiation, including severe hypoglycemia, diabetic ketoacidosis, or infections\n* Use of weight-affecting products within the past three months or planned use during the study\n* Weight fluctuation \\>5 kg or \\>10% within the past three months\n* Obesity or overweight due to endocrine disorders (such as thyroid dysfunction or Cushing's syndrome)\n* Uncontrolled hypertension, severe cardiac\u002Fhepatic\u002Frenal dysfunction\n* History of gastrointestinal surgery (such as cholecystectomy) within the past year or non-gastrointestinal surgery within six months, or prior bariatric surgery\n* Chronic gastrointestinal disorders (such as recurrent constipation, celiac disease, or food intolerances) or any condition impairing digestion\u002Fabsorption function\n* History of malignant tumors within five years, regardless of whether there is recurrence or metastasis and severe immune dysfunction (such as malignant tumors, HIV\u002FAIDS, immunodeficiency diseases)\n* Use of probiotics, prebiotics, or antibiotics within three months prior to enrollment, or alcohol abuse; Consumption of yogurt within two weeks before the study or during the trial period; History of psychiatric or infectious diseases\n* Pregnancy, lactation, or plans for pregnancy during the study\n* Participation in other clinical trials within the past three months\n* Any condition that in the judgement of the investigator precludes participation","ALL","18 Years","60 Years",{"count":152,"type":153},40,"ESTIMATED","INTERVENTIONAL",[156],"NA","To explore the safety and efficacy of attapulgite in the treatment of obese individuals or overweight\u002Fobese individuals with type 2 diabetes.",[159],"Obesity",[161,162,163,164],"attapulgite","obesity","placebo-controlled study","randomized controlled trial","2025-08-30",{"date":167,"type":168},"2025-09-05","ACTUAL",{"date":170,"type":168},"2025-06-26",{"date":172,"type":153},"2025-12",{"name":5,"class":6},1]