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NCT Number: NCT05414409

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

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Body Weight Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

11 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Overweight/obese youth 11-18 years of age with T1D at time of enrollment.
  • Lean youth 11-18 years of age with T1D at time of enrollment.

Exclusion criteria

  • Known monogenic forms of diabetes or Type 2 diabetes (confirmed clinically and by genetic/antibody testing).
  • History of ongoing infection or antibiotic treatment within the past month;
  • History of immune-compromise, recurrent infections, steroid intake (inhaled or oral forms) or other immunosuppressant use in the past 6 months.
  • History of chronic gastrointestinal disease and active within the past 6 months, possible or confirmed celiac disease.
  • Participation in any research intervention trials within the past 3 months.
  • History of treatment or use of metformin, a type 2 diabetes medication.

Treatment and study plan

metformin

Drug

Metformin is an oral medication that improves insulin sensitivity.

Primary outcomes

  1. Differences in the gut microbiome in lean and overweight/obese youth with type 1 diabetes

    Time frame: Baseline

    cross sectional comparison of stool microbiome using metagenomic sequencing data

  2. Differences in the gut microbial metabolites in lean and overweight/obese youth with type 1 diabetes

    Time frame: Baseline

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

  3. Differences in the gut microbial metabolites in lean and overweight/obese youth with type 1 diabetes

    Time frame: Baseline

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

  4. Changes in the gut microbiome in overweight/obese youth with type 1 diabetes in response to metformin

    Time frame: Baseline, 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

  5. Changes in the gut microbial metabolites in overweight/obese youth with type 1 in response to metformin

    Time frame: Baseline, 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

Secondary outcomes

  1. Differences in measures of C-peptide as a measure of beta cell health in lean and overweight/obeseT1D youth

    Time frame: Baseline

    The investigators will measure serum C-peptide to calculate a ratio of proinsulin to C-peptide as a marker of beta cell health. These measures will then be compared between the lean and obese T1D youth.

  2. Differences in measures Proinsulin as a measure of beta cell health in lean and overweight/obeseT1D youth

    Time frame: Baseline

    The investigators will measure serum proinsulin and calculate a ratio of proinsulin to C-peptide as a marker of beta cell health. These measures will then be compared between the lean and obese T1D youth.

  3. Differences in measures of insulin sensitivity in lean and overweight/obese T1D youth

    Time frame: Baseline

    Insulin sensitivity will be assessed in individuals using the estimated insulin sensitivity score (eIS), which is based on waist circumference (cm), HbA1c (%) and triglycerides (mg/dl)

  4. Changes in measures of C-peptide as a measure of beta cell health in overweight/obese T1D youth in response to metformin

    Time frame: Baseline, Month 3, and Month 6

    Serum C-peptide will be used to calculate proinsulin to C-peptide ratio as a measure of beta cell health before and after metformin therapy

  5. Changes in measures of proinsulin as a measure of beta cell health in overweight/obese T1D youth in response to metformin

    Time frame: Baseline, Month 3, and Month 6

    Serum proinsulin will be used to calculate proinsulin to C-peptide ratio as a measure of beta cell health before and after metformin therapy

  6. Changes in measures of insulin sensitivity in overweight/obese T1D youth in response to metformin

    Time frame: Baseline, Month 3, and Month 6

    Estimated insulin sensitivity score will be used to assess response metformin therapy

  7. Changes in measures of beta cell function using a timed mixed meal tolerance test

    Time frame: Baseline and Month 6

    Participants in the metformin trial will undergo a standard 2-hour mixed meal tolerance test at baseline and after 6 months of oral metformin therapy

Study contacts

Contact information is provided by the study sponsor or research team.

HI Team

CONTACT

[email protected]

317-274-2114

Heba M Ismail

CONTACT

[email protected]

317-274-2114

Sponsors and collaborators

Lead sponsor

Heba M. Ismail

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

The Gut Microbiome in Lean and Overweight Youth With Type 1 Diabetes and Novel Mechanism of Action of Metformin

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jun 10, 2022
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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