An Open-Label Pilot Intervention Trial to Prevent Diabetes in Prediabetic Adult Survivors of Childhood Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Adult Children
- Prediabetes
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 44 years
- Gender
- Both males and females
Description
Eligible subjects who meet inclusion criteria will receive metformin extended release daily and be enrolled in the digital lifestyle intervention program. Following a 2-week run-in period at lower dose (500 mg/day) to minimize gastrointestinal side effects (diarrhea, nausea, flatulence, bloating), p...
Eligible subjects who meet inclusion criteria will receive metformin extended release daily and be enrolled in the digital lifestyle intervention program. Following a 2-week run-in period at lower dose (500 mg/day) to minimize gastrointestinal side effects (diarrhea, nausea, flatulence, bloating), participants will be escalated to a maximum dose of 1000 mg/day. The digitally delivered lifestyle change program will include a core curriculum focused on diet quality, food types, exercise and behavioral strategies for goal setting, and self-monitoring.
Tracking Information
- NCT #
- NCT04742751
- Collaborators
- St. Baldrick's Foundation
- Investigators
- Principal Investigator: Stephanie Dixon, MD, MPH St. Jude Children's Research Hospital
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