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Taking people in United StatesPhase 2

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.

Plain-language title generated from the registry record
Registry title: The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action

Key facts

Where
Indianapolis, United StatesSee the site
Phase
Phase 2

Could this be for you?

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?

Source: NCT05414409, who can take part

Where in United States

  • Indiana University School of MedicineIndianapolis, United StatesTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Heba M. Ismail
Trial code
NCT05414409
Record updated
21 August 2026
Original description
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.Read full original descriptionShow less

The Gut Microbiome in Lean and Overweight Youth With Type 1 Diabetes and Novel Mechanism of Action of Metformin

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.

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; History of treatment or use of metformin, a type 2 diabetes medication; Participation in any research intervention trials within the past 3 months.

ClinicalTrials.gov NCT05414409