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

Recruiting now · Phase 2

Conditions studied: Type 1 Diabetes, Obesity

In brief

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.

Key facts

Study ID

NCT05414409

Run by

Heba M. Ismail

People needed

114

Starts

2022-09-30

Expected to finish

2026-11-02

Last updated by the study team

2025-07-25

Who can join

Age: 11 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Overweight/obese youth 11-18 years of age with T1D at time of enrollment.
• Lean youth 11-18 years of age with T1D at time of enrollment.

You may not qualify if…

• Known monogenic forms of diabetes or Type 2 diabetes (confirmed clinically and by genetic/antibody testing).
• History of ongoing infection or antibiotic treatment within the past month;
• History of immune-compromise, recurrent infections, steroid intake (inhaled or oral forms) or other immunosuppressant use in the past 6 months.
• History of chronic gastrointestinal disease and active within the past 6 months, possible or confirmed celiac disease.
• Participation in any research intervention trials within the past 3 months.
• History of treatment or use of metformin, a type 2 diabetes medication.

Where it is running

• Indiana University School of Medicine — Indianapolis, Indiana, United States (enrolling)

Full record on ClinicalTrials.gov

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