Precision Dosing of Metformin in Youth With T2D

Description

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).

Conditions

Type 2 Diabetes

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Study Overview

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Study Details

Study overview

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).

Pilot Study of Precision Dosing of Metformin in Youth With Type 2 Diabetes (PRECISE_T2D)

Precision Dosing of Metformin in Youth With T2D

Condition
Type 2 Diabetes
Intervention / Treatment

-

Contacts and Locations

Oakland

UCSF Benioff Children's Hospital Oakland, Pediatric Diabetes Clinic, Oakland, California, United States, 94609

San Francisco

UCSF Benioff Children's Hospital San Francisco, Madison Clinic for Pediatric Diabetes, San Francisco, California, United States, 94158

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

10 Years to 21 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of California, San Francisco,

Shylaja Srinivasan, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

2025-12-31