The Gut Microbiome in Lean and Overweight Youth With Type 1 Diabetes and Novel Mechanism of Action of Metformin

Trial ID: NCT05414409

Interventional - Phase 2 - Recruiting

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.

Conditions

• Type 1 Diabetes
• Obesity

Interventions

• Metformin

Eligibility

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.

Sponsor

Heba M. Ismail, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Source: ClinicalTrials.gov

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