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RECRUITING Phase 2 ClinicalTrials.gov

The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action

Sponsor: Heba M. Ismail • ClinicalTrials.gov ID: NCT05414409

Registry updated: 2026-08-21
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Description

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.

Interventions

  • Metformin (Drug)
    Metformin is an oral medication that improves insulin sensitivity.

Eligibility criteria

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.

Conditions

Type 1 Diabetes Obesity

Locations

  • Indiana University School of Medicine — Indianapolis, Indiana, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record