Active — Not RecruitingPhase 2

An Open-Label Pilot Intervention Trial to Prevent Diabetes in Prediabetic Adult Survivors of Childhood Cancer

United States96 participantsStarted 2022-03-02

Plain-language 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 (including a 12-week lifestyle alone run-in followed by 12-week combined intervention among survivors remaining prediabetic). 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.

Who can participate

Age range18 Years – 44 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Investigators will recruit to enroll 55 survivors who are at least 18 but \<45 years of age who participate in the St. Jude Lifetime Cohort Study (SJLIFE) and have been identified to have prediabetes defined as hemoglobin A1c (HbA1c) * Participant in SJLIFE * ≥18 and \<45 years of age * Prediabetic: fasting plasma glucose 105-125 mg/dL, hemoglobin A1c 5.7- 6.4% (either or both criteria may be present) According to institutional and NIH policy, the study will accession research participants regardless of sex and ethnic background. Institutional experience confirms broad representation in this regard. Exclusion Criteria: * Absence of treatment related diabetes risk. Survivors will be excluded if their cancer treatment required observation only, surgery alone not involving the abdomen or brain, radiation alone not involving the chest (pancreatic risk), abdomen or brain (e.g. retinoblastoma treated with enucleation alone, melanoma of an extremity treated with excision alone, neuroblastoma in an infant requiring observation only) * Diabetes at baseline assessment: FPG ≥126 mg/dL, HbA1c ≥6.5% or previous diagnosis by a physician (except gestational diabetes that resolved post-partum) * BMI \<19 kg/m2 * Current metformin use (including for any period ≥30 days in the past 1yr) * Known allergy to metformin * Current use of other oral glucose lowering medications, non-insulin injectable diabetes medications or insulin (Appendix) * Current participation in a lif…

What they're measuring

Adherence for feasibility

Timeframe: 2 years

Digitally-delivered core education curriculum through the lifestyle change platform

Timeframe: At end of Week 24

Safety and Adverse Events (Symptom Log including monitoring for AEs)

Timeframe: Week 4

Safety and Adverse Events (Symptom Log including monitoring for AEs)

Timeframe: Week 8

Safety and Adverse Events (Symptom Log including monitoring for AEs)

Timeframe: Week 12

Safety and Adverse Events (Symptom Log including monitoring for AEs)

Timeframe: Week 14

Safety and Adverse Events (Symptom Log including monitoring for AEs)

Timeframe: Week 16

Safety and Adverse Events (Symptom Log including monitoring for AEs)

Timeframe: Week 20

Trial details

NCT IDNCT04742751

SponsorSt. Jude Children's Research Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-16

View on ClinicalTrials.gov More PreDiabetes trials

Plain-language summary

Who can participate

Age range18 Years – 44 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Adherence for feasibility

Timeframe: 2 years

Digitally-delivered core education curriculum through the lifestyle change platform

Timeframe: At end of Week 24

Safety and Adverse Events (Symptom Log including monitoring for AEs)

Timeframe: Week 4

Safety and Adverse Events (Symptom Log including monitoring for AEs)

Timeframe: Week 8

Safety and Adverse Events (Symptom Log including monitoring for AEs)

Timeframe: Week 12

Safety and Adverse Events (Symptom Log including monitoring for AEs)

Timeframe: Week 14

Safety and Adverse Events (Symptom Log including monitoring for AEs)

Timeframe: Week 16

Safety and Adverse Events (Symptom Log including monitoring for AEs)

Timeframe: Week 20