RECRUITING

Precision Dosing of Metformin in Youth With T2D

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Conditions

Type 2 Diabetesmetforminpediatric

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2024-04-01
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06120881

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.

Ages Eligible for Study:10 Years to 21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 10-21 years
  2. * Provider diagnosis of T2D
  3. * Stable medication regimen for 2 weeks before screening visit (No addition or removal of medications and no more than 20% change in insulin dose)
  4. * ≥ 1 month from T2D diagnosis
  5. * Taking regular metformin (not extended-release formula)
  6. * Ability to wear CGM for a total of 6 weeks while in the study.
  7. * English or Spanish speakers.
  8. * Willing to abide by recommendations and study procedures.
  9. * Willing and able to sign the Informed Consent Form (ICF) and/or has a parent or guardian willing and able to sign the ICF.
  10. * 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.
  1. * Pancreatic autoantibody positivity (GAD-65, insulin, IA-2, ICA 512, Zn-T8).
  2. * Known history of ongoing renal or hepatic disease.
  3. * Known history of significant mental illness or developmental delay impacting the ability to complete study activities independently.

Contacts and Locations

Study Contact

Avani A Narayan, MS
CONTACT
628-224-8364
avani.narayan@ucsf.edu
Laura A. Dapkus Humphries, NCPT
CONTACT
628-224-8364
laura.dapkus@ucsf.edu

Principal Investigator

Shylaja Srinivasan, MD
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of California, San Francisco

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-01
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2024-04-01
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • Type 2 Diabetes
  • metformin
  • pediatric

Additional Relevant MeSH Terms

  • Type 2 Diabetes