Precision Dosing of Metformin in Youth With T2D

Part of paid clinical trials in Oakland, California.

Sponsor
University of California, San Francisco
Study ID
NCT06120881
Phase
EARLY_PHASE1
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
10 Years - 21 Years
Healthy Volunteers
Accepted

Interventions

  • Metformin — DRUG
    Participants will receive either 2700mg of metformin/day (1350mg twice a day) or 2000mg of metformin/day (1000mg twice a day, standard of care). The study intervention will be blinded to the participants as they will receive the same number of pills (4 pills of the same size) regardless of whether they are in the intervention arm or control arm .

Study Details

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).

Key Dates

Start date
Apr 25, 2024
Status verified
Dec 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental
    1350mg metformin twice per day
  • Active Comparator: Active Comparator
    1000mg metformin twice per day

Primary Outcome Measure

Acceptability of Higher Metformin Dose measured with the Acceptability of Intervention Measure (AIM) [ Time Frame: Measured at 3 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
UCSF Benioff Children's Hospital Oakland, Pediatric Diabetes ClinicOaklandCalifornia94609
Shylaja Srinivasan, MD
415-353-9084
Laura A Dapkus AD Humphries, NCPT
628-224-8364
Shylaja Srinivasan, MD (PRINCIPAL_INVESTIGATOR)
UCSF Benioff Children's Hospital San Francisco, Madison Clinic for Pediatric DiabetesSan FranciscoCalifornia94158
Shylaja A Srinivasan, MD
415-353-9084
Laura A Dapkus Humphries, NCPT
628-224-8364
Shylaja Srinivasan, MD (PRINCIPAL_INVESTIGATOR)

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