The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action
NCT ID: NCT05414409
Last Updated: 2025-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
114 participants
INTERVENTIONAL
2022-09-30
2026-11-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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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.
No interventions assigned to this group
Metformin
This is a group of 30 youth with type 1 diabetes and overweight/obesity who will receive metformin for 6 months.
Metformin
Metformin is an oral medication that improves insulin sensitivity.
Interventions
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Metformin
Metformin is an oral medication that improves insulin sensitivity.
Eligibility Criteria
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Inclusion Criteria
2. Lean youth 11-18 years of age with T1D at time of enrollment.
Exclusion Criteria
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.
11 Years
18 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Heba M. Ismail
OTHER
Responsible Party
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Heba M. Ismail
Assistant Professor of Pediatrics
Locations
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Indiana University School of Medicine
Indianapolis, Indiana, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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15498
Identifier Type: -
Identifier Source: org_study_id
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