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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: Completed NA study, sponsored by University of Michigan.
NCT05235425 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 304 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
HbA1c levels will be measured by standard immunoturbidimetric assay methods and quality control measures at a Clinical Laboratory Improvement Amendments (CLIA) certified lab.
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 |
What the finished NCT05235425 record still lists
NCT05235425 is an interventional study that assigns participants to a tested intervention. The registered 304 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 2 interventions - of which Very low-carbohydrate diet is the first listed.
NCT05235425 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05235425's enrollment target sits among peer trials
304 327th of 2000 higher than 1,672 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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