Metformin for Type 1 Diabetes and Obesity
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used metformin before.
Is metformin safe for humans?
How does the drug metformin differ from other treatments for type 1 diabetes and obesity?
Metformin is unique because it helps improve insulin sensitivity and control blood sugar without causing weight gain, and it may even promote some weight loss, which is beneficial for obese patients with type 1 diabetes. Unlike insulin therapy, which often leads to weight gain, metformin offers a weight-neutral or weight-reducing option.26789
What is the purpose of this trial?
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 obesity as well as potential mechanisms to modify disease.
Eligibility Criteria
This trial is for obese and lean youths aged 11-18 with Type 1 Diabetes (T1D). They should not have participated in other research trials within the last 3 months, had infections or antibiotic treatments in the past month, used metformin, or have chronic gastrointestinal diseases including celiac disease. Those with monogenic diabetes forms or immune-compromise conditions are also excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive metformin for 6 months to assess changes in gut microbiome and metabolic markers
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Metformin
Find a Clinic Near You
Who Is Running the Clinical Trial?
Heba M. Ismail
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator