NCT05414409PHASE2Recruiting
The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action
Heba M. Ismail
Start Date
9/30/2022
Completion Date
11/2/2026
Summary
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.
Eligibility Criteria
Age Range: 11 years to 18 years
Inclusion Criteria:
1. Overweight/obese youth 11-18 years of age with T1D at time of enrollment.
2. Lean youth 11-18 years of age with T1D at time of enrollment.
Exclusion Criteria:
1. Known monogenic forms of diabetes or Type 2 diabetes (confirmed clinically and by genetic/antibody testing).
2. History of ongoing infection or antibiotic treatment within the past month;
3. History of immune-compromise, recurrent infections, steroid intake (inhaled or oral forms) or other immunosuppressant use in the past 6 months.
4. History of chronic gastrointestinal disease and active within the past 6 months, possible or confirmed celiac disease.
5. Participation in any research intervention trials within the past 3 months.
6. History of treatment or use of metformin, a type 2 diabetes medication.
Interventions
DRUG
Metformin
Conditions
Type 1 DiabetesObesity
Locations
Indiana University School of Medicine
Indianapolis, Indiana 46202
United States