Overview

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

Status:
Not yet recruiting

Trial end date:
2026-08-01

Target enrollment:
0

Participant gender:
All

Summary

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 obesity as well as potential mechanisms to modify disease.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Heba M. Ismail

Treatments:

Metformin

Criteria

Inclusion Criteria:

1. 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, 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.