Exploring the gut microbiome's role in type 1 diabetes and metformin's effects

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.