NCT05414409RecruitingPhase 2
The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action
The Gut Microbiome in Lean and Overweight Youth With Type 1 Diabetes and Novel Mechanism of Action of Metformin
Source: ClinicalTrials.gov · Last updated 21 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 114 (estimated)
- First submitted
- 31 May 2022
- Start date
- 30 Sept 2022
- Primary completion date
- 2 Nov 2026
- Lead sponsor
- Heba M. Ismail
- Diseases
- Obesity, Type 1 diabetes
- NCT number
- NCT05414409
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 114
- From 30 Sept 2022 to the primary completion date, 2 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- History of treatment or use of metformin, a type 2 diabetes medication.
Other
- Participation in any research intervention trials within the past 3 months.
Who the study is looking for
- 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.
Age in the registry: 11 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Indiana University School of Medicine Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.