Preventing diabetes in adult survivors of childhood cancer with prediabetes
An Open-Label Pilot Intervention Trial to Prevent Diabetes in Prediabetic Adult Survivors of Childhood Cancer
This study is testing whether a combination of metformin and a lifestyle program can help adult survivors of childhood cancer who are prediabetic avoid developing diabetes.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 44 Years |
| Sex | All |
| Sponsor | St. Jude Children's Research Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Memphis, Tennessee) |
| Trial ID | NCT04742751 on ClinicalTrials.gov |
What this trial studies
This pilot intervention focuses on adult survivors of childhood cancer who are prediabetic, aiming to assess the feasibility and safety of a combined treatment approach using metformin and a digital lifestyle intervention. Participants will first engage in a 12-week lifestyle program, followed by a 12-week period where they will receive metformin alongside continued lifestyle changes. The study will monitor adherence to medication and lifestyle changes, as well as any side effects experienced. The goal is to establish preliminary evidence for the efficacy of this combined approach in preventing diabetes.
Who should consider this trial
Good fit: Ideal candidates are adult survivors of childhood cancer aged 18 to 45 who are prediabetic.
Not a fit: Patients who do not have treatment-related diabetes risk or who have undergone certain types of cancer treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the risk of diabetes in a vulnerable population of cancer survivors.
How similar studies have performed: While this approach is novel for this specific population, similar interventions combining pharmacologic and lifestyle changes have shown promise in other groups.
Eligibility criteria
Show full inclusion / exclusion criteria
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 lifestyle change program * Chronic kidney disease ≥ stage IIIb (eGFR \< 45 mL/min) * Severe cardiovascular disease or recent intervention (NYHA class ≥2 or heart failure hospitalization in the past 6mo, Aortic stenosis, Heart block including LBBB or 3rd degree AV block, SBP \>180 or DBP \>105 mmHg, myocardial infarction or coronary revascularization in the past 1 month) * Severe hepatic dysfunction: cirrhosis or AST/ALT \>3 times upper limit of normal * Pulmonary disease with dependence on oxygen or daily use of bronchodilators * Weight loss \>10% in the past 6 months * Bariatric surgery in the past 2 years * Pregnant, within 3 months post-partum, nursing, or planning to become pregnant * Anemia: hematocrit \<36% in males or \<33% in females * Ongoing alcohol or substance abuse using criteria from the AUDIT and DAST questionnaires (Appendix) * Diagnosis of schizophrenia or other psychotic disorder * Vision impairment limiting ability to interface with the digital program * Unable to swallow medication * Non-English speaking * Cognitive impairment defined by IQ \<80 * Current active cancer or undergoing treatment for active cancer
Where this trial is running
Memphis, Tennessee
- St. Jude Children's Research Hospital — Memphis, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Stephanie Dixon, MD, MPH — St. Jude Children's Research Hospital
- Study coordinator: Stephanie Dixon, MD, MPH
- Email: referralinfo@stjude.org
- Phone: 866-278-5833
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.