[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100471095":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":24,"locations":33,"responsibleParty":54,"collaborators":58,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":12,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":12,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":12,"overallStatus":36,"whyStopped":12,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Indiana University","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Comparison of microbiome by BMI Category","NO_INTERVENTION","The gut microbiome and metabolites of 42 lean and 42 overweight\u002Fobese youth with type 1 diabetes will be evaluated cross-sectionally.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Metformin","EXPERIMENTAL","This is a group of 30 youth with type 1 diabetes and overweight\u002Fobesity who will receive metformin for 6 months.",[18],"Drug: Metformin",[20],{"type":21,"name":14,"description":22,"armGroupLabels":23,"otherNames":12},"DRUG","Metformin is an oral medication that improves insulin sensitivity.",[14],[25,30],{"name":26,"role":27,"phone":28,"phoneExt":12,"email":29},"Heba M Ismail","CONTACT","317-274-2114","heismail@iu.edu",{"name":31,"role":27,"phone":28,"phoneExt":12,"email":32},"HI Team","hiteam@iu.edu",[34],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Indiana University School of Medicine","RECRUITING","Indianapolis","Indiana","46202","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-86.15804,39.76838,{"lat":46,"lon":45},[49,52],{"name":50,"role":27,"phone":51,"phoneExt":12,"email":29},"Heba Ismail","317-278-7856",{"name":31,"role":27,"phone":53,"phoneExt":12,"email":32},"317-278-7042",{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"SPONSOR_INVESTIGATOR","Heba M. Ismail","Assistant Professor of Pediatrics",[59],{"name":60,"class":61},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","100471095","phase-2-the-gut-microbiome-in-type-1-diabetes-and-mechanism-of-metformin-action-100471095",false,"NCT05414409","The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action","The Gut Microbiome in Lean and Overweight Youth With Type 1 Diabetes and Novel Mechanism of Action of Metformin","Inclusion Criteria:\n\n1. Overweight\u002Fobese youth 11-18 years of age with T1D at time of enrollment.\n2. Lean youth 11-18 years of age with T1D at time of enrollment.\n\nExclusion Criteria:\n\n1. Known monogenic forms of diabetes or Type 2 diabetes (confirmed clinically and by genetic\u002Fantibody testing).\n2. History of ongoing infection or antibiotic treatment within the past month;\n3. History of immune-compromise, recurrent infections, steroid intake (inhaled or oral forms) or other immunosuppressant use in the past 6 months.\n4. History of chronic gastrointestinal disease and active within the past 6 months, possible or confirmed celiac disease.\n5. Participation in any research intervention trials within the past 3 months.\n6. History of treatment or use of metformin, a type 2 diabetes medication.","ALL","11 Years","18 Years",{"count":73,"type":74},114,"ESTIMATED","INTERVENTIONAL",[77],"PHASE2","Ovwerweight and obesity prevalence in persons with T1D has increased, which further complicates management and risk for complications. The proposed study is relevant to public health because it helps us understand the role of the gut microbiome in disease pathophysiology in T1D youth with overweight and obesity as well as potential mechanisms to modify disease.",[80,81],"Type 1 Diabetes","Obesity","2026-08-20",{"date":84,"type":85},"2026-08-21","ACTUAL",{"date":87,"type":85},"2022-09-30",{"date":89,"type":74},"2027-03-01",{"name":56,"class":6},1]