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Precision Dosing of Metformin in Youth With T2D
RECRUITINGEarly 1Sponsored by University of California, San Francisco
Actively Recruiting
PhaseEarly 1
SponsorUniversity of California, San Francisco
Started2024-04-25
Est. completion2026-12-31
Eligibility
Age10 Years – 21 Years
Healthy vol.Accepted
Locations2 sites
View on ClinicalTrials.gov →
NCT06120881
Summary
The purpose of this study to compare the typically prescribed dose of metformin (1000mg twice a day) with a higher dose of metformin (1350mg twice a day).
Eligibility
Age: 10 Years – 21 YearsHealthy volunteers accepted
Inclusion Criteria: * Age 10-21 years * Provider diagnosis of T2D * Stable medication regimen for 2 weeks before screening visit (No addition or removal of medications and no more than 20% change in insulin dose) * ≥ 1 month from T2D diagnosis * Taking regular metformin (not extended-release formula) * Ability to wear CGM for a total of 6 weeks while in the study. * English or Spanish speakers. * Willing to abide by recommendations and study procedures. * Willing and able to sign the Informed Consent Form (ICF) and/or has a parent or guardian willing and able to sign the ICF. * Participant and parent(s)/guardian(s) willingness to participate in all training sessions as directed by study staff. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study. Exclusion Criteria: * Pancreatic autoantibody positivity (GAD-65, insulin, IA-2, ICA 512, Zn-T8). * Known history of ongoing renal or hepatic disease. * Known history of significant mental illness or developmental delay impacting the ability to complete study activities independently.
Conditions2
DiabetesType 2 Diabetes
Locations2 sites
UCSF Benioff Children's Hospital Oakland, Pediatric Diabetes Clinic
Oakland, California, 94609
UCSF Benioff Children's Hospital San Francisco, Madison Clinic for Pediatric Diabetes
San Francisco, California, 94158
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Actively Recruiting
PhaseEarly 1
SponsorUniversity of California, San Francisco
Started2024-04-25
Est. completion2026-12-31
Eligibility
Age10 Years – 21 Years
Healthy vol.Accepted
Locations2 sites
View on ClinicalTrials.gov →
NCT06120881