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NCT05235425 · ClinicalTrials.gov registry record · NA
The Lifestyle Education About Prediabetes (Leap) Study
A NA study, sponsored by University of Michigan.
- Completed
- Registry status
- NA
- Development phase
- 304
- Enrollment target
NCT05235425 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 304 participants.
The verdict
NCT05235425, a NA study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- NA
- Development phase
- 304 participants
- Enrollment target
Study Summary
This research will test whether a standard version or very low-carbohydrate version of the Diabetes Prevention Program better improves outcomes like blood glucose control and body weight for patients with prediabetes. Participants will have screening (includes blood draw) and baseline testing with a continuous glucose monitor. Once these enrollment steps are completed and the participants will be randomized to one of two groups: standard National Diabetes Prevention Program (NDPP) or a very low-carbohydrate version. In addition to the diet (12 months) participants will be asked to participate in hour-long weekly group classes over zoom. After four months in the program, classes will occur about every month to help participants maintain the new diet. There will also be check-ins and follow-up visits through out the study.
Interventions
- BEHAVIORAL Very low-carbohydrate diet
- BEHAVIORAL Standard NDPP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 304 participants |
| Start Date | 2022-03-20 |
| Est. Completion | 2025-11-14 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05235425
The ClinicalTrials.gov registry entry for NCT05235425 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 304 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Very low-carbohydrate diet is the first listed.
NCT05235425 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05235425 about?
NCT05235425 is a clinical study titled "The Lifestyle Education About Prediabetes (Leap) Study". This research will test whether a standard version or very low-carbohydrate version of the Diabetes Prevention Program better improves outcomes like blood glucose control and body weight for patients with prediabetes. Participants will have screening (includes blood draw) and baseline testing with ...
What is the current status of trial NCT05235425?
This trial is currently completed. It is a NA study. The enrollment target is 304 participants. The study started on 2022-03-20. Estimated completion is 2025-11-14.
What interventions are being tested in trial NCT05235425?
The interventions under investigation include: Very low-carbohydrate diet (BEHAVIORAL), Standard NDPP (BEHAVIORAL).
Who is sponsoring clinical trial NCT05235425?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
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