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

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Heba M. Ismail
Study ID
NCT05414409
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
11 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Metformin — DRUG
    Metformin is an oral medication that improves insulin sensitivity.

Study Details

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.

Key Dates

Start date
Sep 30, 2022
Status verified
Jul 2025
Primary completion
Nov 2, 2026
Completion
Nov 2, 2026

Study Design

Enrollment
114 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Differences in the gut microbiome in lean and overweight/obese youth with type 1 diabetes [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Indiana University School of MedicineIndianapolisIndiana46202
Heba Ismail
[email protected]
317-278-7856
HI Team
[email protected]
317-278-7042

Find similar trials in Indianapolis, IN

By condition
Obesity / overweightType 1 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Indiana University School of Medicine· Indianapolis, IN

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