Gut Microbiome Study for Type 1 Diabetes in Youth

The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action

Recruiting Phase 2 Interventional Study
Type 1 Diabetes Obesity
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
11 – 18
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
114 (estimated)
Sponsor
Heba M. Ismail · Other
Who this trial is looking for

This trial is looking for young people aged 11-18 with Type 1 Diabetes who are overweight, obese, or lean. Participants will help researchers understand the role of gut bacteria in Type 1 Diabetes and how a diabetes medication called metformin might work.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am 11-18 years old and have Type 1 Diabetes.
  • I am overweight or obese.

You may not be able to join if

  • I have a known genetic form of diabetes or Type 2 diabetes.
  • I have had an ongoing infection or been on antibiotics in the past month.
  • I have a history of weak immune system or recurrent infections in the past 6 months.
  • I have had chronic gut issues or celiac disease active in the past 6 months.
  • I have participated in another research trial in the past 3 months.
  • I have been treated with metformin before.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

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About This Trial

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.

Trial Locations
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Eligibility 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. …
Contacts

Heba M Ismail

317-274-2114

heismail@iu.edu

CONTACT

HI Team

317-274-2114

hiteam@iu.edu

CONTACT