An Open-Label Pilot Intervention Trial to Prevent Diabetes in Prediabetic Adult Survivors of Childhood Cancer
Status:
Recruiting
Trial end date:
2025-03-01
Target enrollment:
Participant gender:
Summary
This is a first-in survivor, single-arm pilot study with the goal of establishing evidence of
feasibility and safety of a combined pharmacologic (metformin) and lifestyle intervention
(using an existing digital platform) to prevent diabetes in prediabetic adult survivors of
childhood cancer.
Primary Objective
The primary aim of this proposal is to establish the feasibility and safety of a 24-week
combined metformin + intensive lifestyle intervention among adult survivors with prediabetes.
Primary endpoints of this trial will be adherence to 1) daily metformin administration and 2)
completion of required core-curriculum of the lifestyle change intervention. Safety will be
assessed using the Global Rating of Side Effects Burden
Secondary Objectives
The secondary aim is to assess preliminary evidence for efficacy of the combined metformin +
intensive lifestyle intervention on glycemic control and insulin resistance. Glycemic control
will be measured by fasting plasma glucose (FPG) and hemoglobin A1c (HbA1c) and insulin
resistance measured by the homeostatic model assessment (HOMA-IR) and IGF- binding protein 1
(IGF-BP1; a measure of insulin sensitivity strongly correlated with euglycemic insulin clamp
testing).
Exploratory Objectives
To assess preliminary evidence for efficacy of the combined metformin + intensive lifestyle
intervention on weight, other anthropometric measures, blood pressure and lipid profile,
physical activity (self-reported and as measured by accelerometer), frailty measures, and
health-related quality of life (HRQOL). We will also assess diabetes development at future
SJLIFE visits.
To assess measures of participation in the lifestyle change program as well as barriers to
participation and medication adherence.