Precision Dosing of Metformin in Youth With T2D

Официальное название

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

Обзор

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).

Подробное описание

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).

Вмешательства

• Препарат Metformin
  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 .

Первичные конечные точки

• Acceptability of Higher Metformin Dose measured with the Acceptability of Intervention Measure (AIM) [Срок оценки: Measured at 3 months]
• Feasibility of Higher Metformin Dose measured with the Feasibility of Intervention Measure (FIM) [Срок оценки: Measured at 3 months]

Вторичные конечные точки (9)

• Glycemic Change [Срок оценки: Baseline (0) to 3 months]
• Time in target glucose range [Срок оценки: Baseline (0) to 3 months]
• Time above high glucose range [Срок оценки: Baseline (0) to 3 months]
• Time above glucose range [Срок оценки: Baseline (0) to 3 months]
• Time in glucose range [Срок оценки: Baseline (0) to 3 months]
• Time below glucose range [Срок оценки: Baseline (0) to 3 months]
• Time below low glucose range [Срок оценки: Baseline (0) to 3 months]
• Glucose management indicator [Срок оценки: Baseline (0) to 3 months]
• Co-efficient of variation of glucose [Срок оценки: Baseline (0) to 3 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• UCSF Benioff Children's Hospital Oakland, Pediatric Diabetes Clinic — Oakland
• UCSF Benioff Children's Hospital San Francisco, Madison Clinic for Pediatric Diabetes — San Francisco

Идентификаторы

NCT: NCT06120881 · 23-39745 · K23DK120932

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗