Understanding the Gut Microbiome in Type 1 Diabetes and Metformin Action

This study is exploring the gut microbiome (the community of bacteria in your intestines) in young people aged 11-18 with Type 1 Diabetes (T1D). Researchers are looking at how the gut microbiome and its byproducts (metabolites) differ between those who are lean and those who are overweight or obese. The study aims to understand the role of the gut microbiome in T1D, especially when obesity is also present, and how a medication called Metformin might affect this. The main goals are to identify these differences at the beginning of the study. We don't have information on the current recruitment status.

Study design
This interventional study plans to enroll 114 participants. It is exploring the effects of Metformin.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

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NCT05414409

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

Recruiting
PHASE2Ages 11–18InterventionalTreatment
Heba M. Ismail
~114 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:Metformin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Differences in the gut microbiome in lean and overweight/obese youth with type 1 diabetes
Measured over Baseline
+4 more outcomes measured
Type 1 Diabetes
Obesity
1 sites across 1 states
Indiana1

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  • Differences in the gut microbiome in lean and overweight/obese youth with type 1 diabetesBaseline

    cross sectional comparison of stool microbiome using metagenomic sequencing data

  • Differences in the gut microbial metabolites in lean and overweight/obese youth with type 1 diabetesBaseline

    The investigators will measure and compare the stool and serum short chain fatty acids using mass spectrometry

  • Differences in the gut microbial metabolites in lean and overweight/obese youth with type 1 diabetesBaseline

    The investigators will measure and compare the stool and serum secondary bile acids using mass spectrometry

  • Changes in the gut microbiome in overweight/obese youth with type 1 diabetes in response to metforminBaseline, Month 3, and Month 6

    longitudinal comparison before and after taking metformin for 6 months, stool samples will be collected at baseline, 3 months and 6 months and sequenced for microbiome profile using metagenomic sequencing

  • Changes in the gut microbial metabolites in overweight/obese youth with type 1 in response to metforminBaseline, Month 3, and Month 6

    The investigators will measure and compare the stool and serum metabolites (short chain fatty acids and secondary bile acids) before, during and after 6 months of daily metformin therapy using mass spectrometry