Clinical trial NCT05414409: The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action
Official title: The Gut Microbiome in Lean and Overweight Youth With Type 1 Diabetes and Novel Mechanism of Action of Metformin
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Type 1 Diabetes
Obesity
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2022-06-10
Enrollment: 114
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The investigators will examine the differences in the gut microbiome between lean and obese youth with type 1 diabetes and then enroll the obese youth with type 1 diabetes into the clinical trial to receive metformin as an intervention.
Primary purpose: TREATMENT

Brief summary: 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 obesity as well as potential mechanisms to modify disease.


Eligibility criteria: Inclusion Criteria:

1. 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, 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.

Primary outcomes:
measure: Differences in the gut microbiome in lean and obese youth with type 1 diabetes
timeFrame: Baseline
measure: Differences in the gut microbial metabolites in lean and obese youth with type 1 diabetes
timeFrame: Baseline
measure: Differences in the gut microbial metabolites in lean and obese youth with type 1 diabetes
timeFrame: Baseline
measure: Changes in the gut microbiome in obese youth with type 1 diabetes in response to metformin
timeFrame: Baseline, Month 3, and Month 6
measure: Changes in the gut microbial metabolites in obese youth with type 1 in response to metformin
timeFrame: Baseline, Month 3, and Month 6
Secondary outcomes:
measure: Differences in measures of C-peptide as a measure of beta cell health in lean and obese T1D youth
timeFrame: Baseline
measure: Differences in measures Proinsulin as a measure of beta cell health in lean and obese T1D youth
timeFrame: Baseline
measure: Differences in measures of insulin sensitivity in lean and obese T1D youth
timeFrame: Baseline
measure: Changes in measures of C-peptide as a measure of beta cell health in obese T1D youth in response to metformin
timeFrame: Baseline, Month 3, and Month 6
measure: Changes in measures of proinsulin as a measure of beta cell health in obese T1D youth in response to metformin
timeFrame: Baseline, Month 3, and Month 6
measure: Changes in measures of insulin sensitivity in obese T1D youth in response to metformin
timeFrame: Baseline, Month 3, and Month 6
measure: Changes in measures of beta cell function using a timed mixed meal tolerance test
timeFrame: Baseline and Month 6
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
Study officials:
References: