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NCT04742751 · ClinicalTrials.gov registry record · Phase 2
An Open-Label Pilot Intervention Trial to Prevent Diabetes in Prediabetic Adult Survivors of Childhood Cancer
A Phase 2 study of PreDiabetes and Adult Children, sponsored by St. Jude Children's Research Hospital.
- Active
- Registry status
- Phase 2
- Development phase
- 96
- Enrollment target
- 1
- Study location
NCT04742751: Active Phase 2 study of PreDiabetes and Adult Children, sponsored by St. Jude Children's Research Hospital.
NCT04742751 is a Phase 2 study of PreDiabetes and Adult Children that is active but no longer recruiting, run by St. Jude Children's Research Hospital. The registered enrollment target is 96 participants, below the 701-participant average among 149 other PreDiabetes trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04742751, a Phase 2 study of PreDiabetes and Adult Children, is active but no longer recruiting, sponsored by St. Jude Children's Research Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 96 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Adherence to the intervention with 80% adherence to prescribed metformin and completion of 60% of the digitally-delivered core education curriculum through the lifestyle change platform.
Conditions Studied
Interventions
- DRUG Metformin
- BEHAVIORAL Digital Intervention
Study Locations (1)
Tennessee
- St. Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2022-03-02 |
| Est. Completion | 2027-03 |
| Phase | Phase 2 |
What the registry record for NCT04742751 still lists
NCT04742751 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 701-participant average among 149 other PreDiabetes trials with a reported enrollment target (86% lower).
The record links to 2 conditions, with PreDiabetes appearing as the primary indexed condition, and to 2 interventions - of which Metformin is the first listed.
NCT04742751 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT04742751 about?
NCT04742751 is a clinical study titled "An Open-Label Pilot Intervention Trial to Prevent Diabetes in Prediabetic Adult Survivors of Childhood Cancer". 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. Primar...
What is the current status of trial NCT04742751?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 96 participants. The study started on 2022-03-02. Estimated completion is 2027-03.
What conditions does trial NCT04742751 study?
This clinical trial studies the following conditions: PreDiabetes, Adult Children.
What interventions are being tested in trial NCT04742751?
The interventions under investigation include: Metformin (DRUG), Digital Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT04742751?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04742751 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04742751's enrollment target sits among peer trials
96 65th of 149 higher than 84 of 149 other PreDiabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other PreDiabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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