Recruiting
Phase 2

Metformin

Sponsor:

Heba M. Ismail

Code:

NCT05414409

Conditions

Type 1 Diabetes

Obesity

Eligibility Criteria

Sex: All

Age: 11 - 18

Healthy Volunteers: Not accepted

Interventions

Metformin

Study Details

Brief summary:

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.

Conditions

Type 1 Diabetes

Obesity

Study ID

NCT05414409

Start date

Sep 30, 2022

Status verified date

Jul, 2026

Completion date

Mar 1, 2027

Anticipated

Primary completion date

Nov 2, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 11 - 18

Healthy Volunteers: Not accepted

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 Design

Enrollment

114 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Comparison of microbiome by BMI Category

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

experimental: Metformin

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

Interventions

Metformin

Metformin is an oral medication that improves insulin sensitivity.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Heba M Ismail

317-274-2114heismail@iu.edu

HI Team

317-274-2114hiteam@iu.edu

Locations

Indiana University School of Medicine

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Heba Ismail

317-278-7856heismail@iu.edu

HI Team

317-278-7042hiteam@iu.edu

More Information

Sponsor

Heba M. Ismail

Last update posted

Aug 21, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Heba M. Ismail on 2026-08-21.