Menu
Recruiting NCT05414409

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

Phase II Interventional Type 1 Diabetes Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Metformin.
Who it may be relevant to
Registry conditions: Type 1 Diabetes, Obesity. Basic parameters: 11 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Metformin
    Metformin is an oral medication that improves insulin sensitivity.

Primary outcome measures

  • Differences in the gut microbiome in lean and overweight/obese youth with type 1 diabetes [Time frame: Baseline]
  • Differences in the gut microbial metabolites in lean and overweight/obese youth with type 1 diabetes [Time frame: Baseline]
  • Differences in the gut microbial metabolites in lean and overweight/obese youth with type 1 diabetes [Time frame: Baseline]
  • 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]
  • 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]
Secondary outcome measures (7)
  • Differences in measures of C-peptide as a measure of beta cell health in lean and overweight/obeseT1D youth [Time frame: Baseline]
  • Differences in measures Proinsulin as a measure of beta cell health in lean and overweight/obeseT1D youth [Time frame: Baseline]
  • Differences in measures of insulin sensitivity in lean and overweight/obese T1D youth [Time frame: Baseline]
  • 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]
  • 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]
  • Changes in measures of insulin sensitivity in overweight/obese T1D youth in response to metformin [Time frame: Baseline, Month 3, and Month 6]
  • Changes in measures of beta cell function using a timed mixed meal tolerance test [Time frame: Baseline and Month 6]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Indiana University School of Medicine — Indianapolis

Identifiers

NCT: NCT05414409 · 15498 · 1K23DK129799

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗