New hope: preventing diabetes in childhood cancer survivors
NCT ID NCT04742751
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a combination of the diabetes drug metformin and a digital lifestyle program can safely prevent diabetes in adult survivors of childhood cancer who have prediabetes. About 96 participants will first try lifestyle changes alone for 12 weeks, then add metformin for another 12 weeks. The main goals are to see if people can stick with the program and if it improves blood sugar control.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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96 people
The number who actually took part.
- Started
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Mar 2022
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 44 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
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Other studies related to the condition(s) this trial covers.
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