Clinical trial

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

Recruiting now · Phase 2 · 1 countries · Registry ID NCT05414409

Recruiting nowPhase 2Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age11 Years to 18 Years

SexAll

Healthy volunteersNot accepted

ConditionType 1 Diabetes, Obesity

Full registry 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.

Treatments and study arms

Metformin

Drug

Metformin is an oral medication that improves insulin sensitivity.

Primary outcomes

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

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Indiana University School of Medicine🇺🇸 Indianapolis, Indiana, United States

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Heba IsmailContact

Email · Call 317-278-7856

HI TeamContact

Email · Call 317-278-7042