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

Heba M. Ismail

Status and phase: Enrolling; Phase 2

Conditions: Type 1 Diabetes; Obesity

Treatments: Drug: Metformin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05414409

15498

1K23DK129799 (U.S. NIH Grant/Contract)

Details and patient eligibility

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.

Enrollment: 114 estimated patients

Sex: All

Ages: 11 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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114 participants in 2 patient groups

Comparison of microbiome by BMI Category

No Intervention group

Description:

The gut microbiome and metabolites of 42 lean and 42 overweight/obese youth with type 1 diabetes will be evaluated cross-sectionally.

Metformin

Experimental group

Description:

This is a group of 30 youth with type 1 diabetes and overweight/obesity who will receive metformin for 6 months.

Treatment:

Drug: Metformin