Clinical trial NCT06120881: Precision Dosing of Metformin in Youth With T2D
Official title: Pilot Study of Precision Dosing of Metformin in Youth With Type 2 Diabetes (PRECISE_T2D)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes
metformin
pediatric
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-11-07
Enrollment: 20
Sex: ALL
Minimum age (years): 10
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed description: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Acceptability of Higher Metformin Dose measured with the Acceptability of Intervention Measure (AIM)
timeFrame: Measured at 3 months
measure: Feasibility of Higher Metformin Dose measured with the Feasibility of Intervention Measure (FIM)
timeFrame: Measured at 3 months
Secondary outcomes:
measure: Glycemic Change
timeFrame: Baseline (0) to 3 months
measure: Time in target glucose range
timeFrame: Baseline (0) to 3 months
measure: Time above high glucose range
timeFrame: Baseline (0) to 3 months
measure: Time above glucose range
timeFrame: Baseline (0) to 3 months
measure: Time in glucose range
timeFrame: Baseline (0) to 3 months
measure: Time below glucose range
timeFrame: Baseline (0) to 3 months
measure: Time below low glucose range
timeFrame: Baseline (0) to 3 months
measure: Glucose management indicator
timeFrame: Baseline (0) to 3 months
measure: Co-efficient of variation of glucose
timeFrame: Baseline (0) to 3 months
Other outcomes:
Locations:
city: Oakland
country: United States
facility: UCSF Benioff Children's Hospital Oakland, Pediatric Diabetes Clinic
state: California
city: San Francisco
country: United States
facility: UCSF Benioff Children's Hospital San Francisco, Madison Clinic for Pediatric Diabetes
state: California
Study officials:
affiliation: University of California, San Francisco
name: Shylaja Srinivasan, MD
role: PRINCIPAL_INVESTIGATOR
References: