Actively Recruiting

Phase 2
Age: 11Years - 18Years
All Genders
NCT05414409

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

Led by Heba M. Ismail · Updated on 2025-07-25

114

Participants Needed

1

Research Sites

213 weeks

Total Duration

On this page

Sponsors

H

Heba M. Ismail

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 11Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Youth aged 11 to 18 years with type 1 diabetes who are overweight or obese at enrollment
  • Youth aged 11 to 18 years with type 1 diabetes who are lean at enrollment
Not Eligible

You will not qualify if you...

  • Known monogenic forms of diabetes or type 2 diabetes confirmed clinically or by testing
  • Ongoing infection or antibiotic treatment within the past month
  • Immune-compromise, recurrent infections, or use of steroids or immunosuppressants in the past 6 months
  • Chronic gastrointestinal disease active in the past 6 months, including possible or confirmed celiac disease
  • Participation in other research intervention trials in the past 3 months
  • Previous treatment with metformin or other type 2 diabetes medications

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Indiana University School of Medicine

Indianapolis, Indiana, United States, 46202

Actively Recruiting

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Research Team

H

Heba M Ismail

CONTACT

H

HI Team

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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