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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 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 690-participant average among 89 other PreDiabetes trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04742751
The ClinicalTrials.gov registry entry for NCT04742751 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 690-participant average among 89 other PreDiabetes trials with a reported enrollment target (86% lower). The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Related
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