Status:
RECRUITING
The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action
Lead Sponsor:
Heba M. Ismail
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Type 1 Diabetes
Obesity
Eligibility:
All Genders
11-18 years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 2 2026
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT05414409
Start Date
September 30 2022
End Date
November 2 2026
Last Update
July 25 2025
Active Locations (1)
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1
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202