Exploring the gut microbiome's role in type 1 diabetes and metformin's effects
The Gut Microbiome in Lean and Overweight Youth With Type 1 Diabetes and Novel Mechanism of Action of Metformin
This study is testing how the gut bacteria of obese teens with type 1 diabetes affects their condition and whether the diabetes drug metformin can help improve their health.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 114 (estimated) |
| Ages | 11 Years to 18 Years |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT05414409 on ClinicalTrials.gov |
What this trial studies
This study investigates the relationship between the gut microbiome and type 1 diabetes (T1D) in obese youth aged 11-18. It aims to understand how the gut microbiome influences disease progression and the mechanisms through which metformin, a diabetes medication, may modify these effects. By comparing obese and lean youth with T1D, the study seeks to uncover potential therapeutic targets for improving management of the disease. The findings could provide insights into personalized treatment strategies for T1D patients.
Who should consider this trial
Good fit: Ideal candidates for this study are obese and lean youth aged 11-18 who have been diagnosed with type 1 diabetes.
Not a fit: Patients with monogenic forms of diabetes, type 2 diabetes, or those with certain gastrointestinal diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for type 1 diabetes in youth, particularly those who are obese.
How similar studies have performed: While the role of the gut microbiome in diabetes is an emerging field, this specific approach combining metformin and T1D in youth is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Overweight/obese youth 11-18 years of age with T1D at time of enrollment. 2. Lean youth 11-18 years of age with T1D at time of enrollment. Exclusion Criteria: 1. Known monogenic forms of diabetes or Type 2 diabetes (confirmed clinically and by genetic/antibody testing). 2. History of ongoing infection or antibiotic treatment within the past month; 3. History of immune-compromise, recurrent infections, steroid intake (inhaled or oral forms) or other immunosuppressant use in the past 6 months. 4. History of chronic gastrointestinal disease and active within the past 6 months, possible or confirmed celiac disease. 5. Participation in any research intervention trials within the past 3 months. 6. History of treatment or use of metformin, a type 2 diabetes medication.
Where this trial is running
Indianapolis, Indiana
- Indiana University School of Medicine — Indianapolis, Indiana, United States (Recruiting)
Study contacts
- Study coordinator: Heba M Ismail
- Email: heismail@iu.edu
- Phone: 317-274-2114
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.