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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
11 Years to 18 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at gut microbes, the tiny living things in the gut, in youth with type 1 diabetes. It aims to learn how these microbes may affect the disease and how metformin, a diabetes medicine, works. It includes youth ages 11–18 who are lean, overweight, or have obesity.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are 11–18 years old when joining the study and have type 1 diabetes.
  • Are lean, overweight, or have obesity.

Who can't join

  • Have diabetes caused by a change in a single gene, or have type 2 diabetes.
  • Have a history of an ongoing infection or took antibiotics in the past month.
  • Have a history of a weak immune system or repeated infections, or used steroids (inhaled or by mouth) or other medicines that weaken the immune system in the past 6 months.
  • Have a long-term stomach or bowel disease that was active in the past 6 months, or have possible or confirmed celiac disease (an illness triggered by gluten).
  • Took part in a research study testing a treatment or other health change in the past 3 months.
  • Have ever taken metformin, a medicine for type 2 diabetes.

Simplified for readability. The official criteria below are what the study team uses.

Official 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. 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.

Study sites (1)

IN