The Gut Microbiome in Lean and Overweight Youth With Type 1 Diabetes and Novel Mechanism of Action of Metformin
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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 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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 11
Maximum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Indiana
Indiana University School of Medicine
RECRUITING
Indianapolis
Contact Information
Primary
Heba M Ismail
heismail@iu.edu
317-274-2114
Backup
HI Team
hiteam@iu.edu
317-274-2114
Time Frame
Start Date: 2022-09-30
Estimated Completion Date: 2026-11-02
Participants
Target number of participants: 114
Treatments
No_intervention: Comparison of microbiome by BMI Category
The gut microbiome and metabolites of 42 lean and 42 overweight/obese youth with type 1 diabetes will be evaluated cross-sectionally.
Experimental: Metformin
This is a group of 30 youth with type 1 diabetes and overweight/obesity who will receive metformin for 6 months.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Heba M. Ismail