NCT05235425 (LEAP) is a NA clinical trial of Standard NDPP in PreDiabetes, sponsored by University of Michigan.

Who is sponsoring NCT05235425?

NCT05235425 is sponsored by University of Michigan.

What drugs are being tested in NCT05235425?

Interventions in NCT05235425: Standard NDPP, Very low-carbohydrate diet.

What condition does NCT05235425 study?

NCT05235425 studies PreDiabetes.

Is NCT05235425 still recruiting?

NCT05235425 is currently completed. Last updated 19 December 2025.

Last reviewed 2025-12-19 · How we verify

NCT05235425: LEAP

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The Lifestyle Education About Prediabetes (Leap) Study

Completed NA Last updated 19 December 2025

What this trial tests

NA trial testing Standard NDPP in PreDiabetes in 304 participants. Completed in 14 November 2025.

Timeline

20 March 2022

Primary endpoint
14 November 2025

14 November 2025

Quick facts

Lead sponsor	University of Michigan
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	304
Start date	20 March 2022
Primary completion	14 November 2025
Estimated completion	14 November 2025
Sites	1 location across United States

Drugs / interventions tested

Standard NDPP
Very low-carbohydrate diet

Conditions studied

PreDiabetes — all drugs for PreDiabetes →

Sponsor

University of Michigan

Who can join

Adults 21 to 75, any sex, with PreDiabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Testing a very low-carbohydrate adaption of the Diabetes Prevention Program among adults with prediabetes: study protocol for the Lifestyle Education about prediabetes (LEAP) trial.
Griauzde DH, O'Brien A, Yancy WS, Richardson CR, et al · · 2022 · cited 4× · PMID 36176003 · DOI 10.1186/s13063-022-06770-3
Testing a very low-carbohydrate adaption of the Diabetes Prevention Program among adults with prediabetes: study protocol for the Lifestyle Education about Prediabetes (LEAP) trial
Griauzde DH, O’Brien A, Yancy WS, Richardson CR, et al · · 2022 · DOI 10.21203/rs.3.rs-1839747/v1

Verify or expand the search:

Other recruiting trials for PreDiabetes

Currently open trials in the same condition.

NCT06897982 — Feasibility of a Nutrition Intervention for Patients With Prediabetes at a Federally Qualified Health Center · NA · recruiting
NCT06967558 — The Role of Islet GLP-1 in the Pathogenesis of Prediabetes · Phase 2 · recruiting
NCT06482944 — Whole Food for Families: A Pilot RCT of a Dietary Guidelines-Based Intervention to Prevent Type 2 Diabetes · NA · recruiting
NCT06989164 — Post Prandial Individual Responses to Different Foods · NA · recruiting
NCT07254572 — Anti-atherosclerotic Efficacy of Selected Antidiabetic Drugs in Patients With Coronary Artery Disease and Pre-diabetes · Phase 4 · recruiting

Other University of Michigan trials

Trials by the same sponsor.

NCT07536919 — Integrating Care for Hypertension-Diabetes MULTImorbidity in Guatemala Through HEARTS Implementation · NA · not yet recruiting
NCT05509842 — Function-based Accelerated Stimulation Therapy (FAST-therapy) for Freezing of Gait (FOG) After Parkinson's Disease (PD) · NA · not yet recruiting
NCT06311188 — Exploring PTSD Symptoms, Barriers and Facilitators to Mindfulness · NA · not yet recruiting
NCT07471646 — Effects of Ramadan Fasting With Exercise on Cardiometabolic Health · NA · not yet recruiting
NCT06671925 — A Community Health Worker-Led Program for Chronic Pain and Loneliness in Older Adults · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05235425 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Michigan
Last refreshed: 19 December 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05235425.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing