This phase II trial studies the effect of metformin and a smartphone application (app)-based lifestyle program, called Noom in preventing diabetes in childhood cancer survivors with blood sugar levels that are higher than normal but not yet high enough to be diabetes (prediabetes). Metformin is a type of antidiabetic drug that decreases the amount of glucose (a type of sugar) released into the bloodstream from the liver and increases the body's use of the glucose. The Noom program includes dietary change and at least 150 minutes/week moderate intensity physical activity (brisk walking, biking, swimming, etc.) using a digital, app-based platform that includes a lifestyle coach who helps facilitate a core-curriculum focused on diet, exercise and behavioral strategies for goal setting and self-monitoring. Giving metformin and the Noom program may help improve blood sugar levels and reduce the risk of developing diabetes.
Additional locations may be listed on ClinicalTrials.gov for NCT04742751.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To establish the feasibility and safety of a 24-week combined digitally-delivered lifestyle intervention and metformin (including a 12-week lifestyle alone run-in followed by 12-week combined intervention among survivors remaining prediabetic) and identify preliminary evidence for efficacy of improved glycemic control and insulin resistance among adult survivors with prediabetes.
SECONDARY OBJECTIVE:
I. To assess preliminary evidence for efficacy of the combined digitally delivered lifestyle intervention and metformin on glycemic control and insulin resistance.
EXPLORATORY OBJECTIVES:
I. To assess preliminary evidence for efficacy of the combined digitally-delivered lifestyle intervention and metformin based on measures of insulin sensitivity (IGF-binding protein 1), body composition, physical activity, frailty, and health-related quality of life as well as preliminary evidence for efficacy by mechanism of prediabetes development (with or without body mass index [BMI] ≥ 25kg/m^2, and with or without insulin resistance).
II. To assess measures of participation in the lifestyle change program as well as barriers to participation and medication adherence.
OUTLINE:
Patients participate in the Noom program including a core curriculum focused on diet, exercise, and behavioral strategies for goal setting and self-monitoring for 24 weeks. Patients that remain prediabetic at week 12 receive metformin hydrochloride orally (PO) once daily (QD) for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection throughout the study.
After completion of study, patients are followed up 6 years.
Lead OrganizationSaint Jude Children's Research Hospital
Principal InvestigatorStephanie Berry Dixon