Precision Dosing of Metformin in Youth With T2D

a study on Diabetes Diabetes Type 2

Summary

Eligibility
for people ages 10-21 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCSF
Dates
study started
completion around
Principal Investigator
by Shylaja Srinivasan, MD (ucsf)
Headshot of Shylaja Srinivasan
Shylaja Srinivasan

Description

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).

Official Title

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

Details

Based on the investigators previous studies of young people who take metformin, the study team found that young people's bodies process metformin faster than older people and young people may need higher doses of metformin for the best treatment outcomes. The purpose of this study is to compare the typically prescribed dose of metformin (1000mg twice a day) with a higher dose of metformin (1350mg twice a day).

Keywords

Type 2 Diabetes, metformin, pediatric, Type 2 Diabetes Mellitus

Eligibility

You can join if…

Open to people ages 10-21

  • 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.

You CAN'T join if...

  • 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.

Locations

  • UCSF Benioff Children's Hospital Oakland, Pediatric Diabetes Clinic accepting new patients
    Oakland California 94609 United States
  • UCSF Benioff Children's Hospital San Francisco, Madison Clinic for Pediatric Diabetes accepting new patients
    San Francisco California 94158 United States

Lead Scientist at University of California Health

  • Shylaja Srinivasan, MD (ucsf)
    I am a clinican-scientist and Assistant Professor of Pediatrics in the Division of Pediatric Endocrinology at UCSF. My clinical and scientific focus is on prediabetes and type 2 diabetes in youth. Specifically, I use pharmacologic and genetic approaches to evaluate pathophysiology and therapeutic strategies for youth with prediabetes and type 2 diabetes.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT06120881
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 20 study participants
Last Updated