Studying gut bacteria and metformin in young people with type 1 diabetes
Tests metformin in youth with type 1 diabetes who are overweight or have obesity.
Key facts
- Who runs it
- Heba M. Ismail
- Where
- Indianapolis, United StatesSee the site
- Trial code
- Registry title
- The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 114 people, planned
- Started
- 30 Sept 2022
- Expected to end
- 1 Mar 2027
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Metformin
- Record updated
- 21 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for young people aged 11-18 years with type 1 diabetes, either overweight or obese, or lean.
- Age
- 11 to 18 years
- Sex
- All sexes can join.
- Disease stage
- Type 1 diabetes, in overweight or obese youth, or in lean youth.
- Earlier treatment
- Cannot have used metformin before. No antibiotics within the past month. No steroids or other immunosuppressant medicine in the past 6 months.
Main reasons for not taking part
- Known monogenic forms of diabetes or type 2 diabetes
- Ongoing infection or antibiotic treatment within the past month
- Weakened immune system, recurrent infections, or steroid or other immunosuppressant use in the past 6 months
- Chronic gut disease active within the past 6 months, or possible or confirmed celiac disease
- Taking part in any research intervention trial within the past 3 months
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Participation in any research intervention trials within the past 3 months
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 11 and 18 years old?
Where in United States
- Indiana University School of MedicineIndianapolis, United StatesContact: Heba IsmailTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Comparison of microbiome by BMI CategoryNo study treatment, for comparison
The gut microbiome and metabolites of 42 lean and 42 overweight/obese youth with type 1 diabetes will be evaluated cross-sectionally.
- MetforminTreatment being tested
This is a group of 30 youth with type 1 diabetes and overweight/obesity who will receive metformin for 6 months.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The Gut Microbiome in Lean and Overweight Youth With Type 1 Diabetes and Novel Mechanism of Action of Metformin
- Plain-language title
- Studying gut bacteria and metformin in young people with type 1 diabetesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT05414409, who can take part
- Record updated
- 21 August 2026