Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
Actively Recruiting
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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