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

Last updated: March 11, 2025
Sponsor: Heba M. Ismail
Overall Status: Active - Recruiting

Phase

2

Condition

Obesity

Diabetes Mellitus Types I And Ii

Diabetes And Hypertension

Treatment

Metformin

Clinical Study ID

NCT05414409
15498
1K23DK129799
  • Ages 11-18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  1. Known monogenic forms of diabetes or Type 2 diabetes (confirmed clinically and bygenetic/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 oralforms) 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.

Study Design

Total Participants: 114
Treatment Group(s): 1
Primary Treatment: Metformin
Phase: 2
Study Start date:
September 30, 2022
Estimated Completion Date:
November 02, 2026

Connect with a study center

  • Indiana University School of Medicine

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

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