The Lifestyle Education About Prediabetes (Leap) Study

NCT ID: NCT05235425

Last Updated: 2025-11-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-20
• Study Completion Date: 2025-11-15

Brief 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.

Conditions

PreDiabetes

Keywords

Very low carbohydrate diet; Diabetes Prevention Program; Nutrition therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard NDPP

12-month long, calorie-restricted NDPP

Group Type: ACTIVE_COMPARATOR

Standard NDPP

Intervention Type: BEHAVIORAL

Participants in this arm will be taught to manage their prediabetes with the Centers for Disease Control's standard National Diabetes Prevention Program. It teaches a lower calorie, lower fat diet.

There will be a core phase and a maintenance phase of this study; the core phase will last for about 4 months and will involve weekly or every other week classes, home assignments, and brief check-in surveys. The maintenance phase will last for the remaining time, with classes and check-in surveys approximately once a month.

Very low-carbohydrate diet (VLCD)

VLCD is an adaptation of the standard NDPP curriculum, which preserves all features with the exception of altered dietary advice.

Group Type: EXPERIMENTAL

Very low-carbohydrate diet

Intervention Type: BEHAVIORAL

Participants in this arm will be taught to manage their prediabetes with the Centers for Disease Control's National Diabetes Prevention Program, adapted to teach a very low-carbohydrate diet, also called a ketogenic or "keto" diet. This diet involves eating non-starchy vegetables, leafy greens, cheese, meats, berries, nuts, and seeds and avoiding starchy foods like pasta, bread, rice, beans, many fruits, etc.

There will be a core phase and a maintenance phase of this study; the core phase will last for about 4 months and will involve weekly or every other week classes, home assignments, and brief check-in surveys. The maintenance phase will last for the remaining time, with classes and check-in surveys approximately once a month.

Interventions

Standard NDPP

Participants in this arm will be taught to manage their prediabetes with the Centers for Disease Control's standard National Diabetes Prevention Program. It teaches a lower calorie, lower fat diet.

There will be a core phase and a maintenance phase of this study; the core phase will last for about 4 months and will involve weekly or every other week classes, home assignments, and brief check-in surveys. The maintenance phase will last for the remaining time, with classes and check-in surveys approximately once a month.

Intervention Type: BEHAVIORAL

Very low-carbohydrate diet

Participants in this arm will be taught to manage their prediabetes with the Centers for Disease Control's National Diabetes Prevention Program, adapted to teach a very low-carbohydrate diet, also called a ketogenic or "keto" diet. This diet involves eating non-starchy vegetables, leafy greens, cheese, meats, berries, nuts, and seeds and avoiding starchy foods like pasta, bread, rice, beans, many fruits, etc.

There will be a core phase and a maintenance phase of this study; the core phase will last for about 4 months and will involve weekly or every other week classes, home assignments, and brief check-in surveys. The maintenance phase will last for the remaining time, with classes and check-in surveys approximately once a month.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• overweight, defined as BMI >= 25 kg/m2 >= 23 kg/m2 if of Asian descent
• HbA1c between 5.7% - 6.4% verified at baseline
• willingness to participate in group-based sessions
• able to engage in at least light physical activities such as walking
• willingness to follow a prescribed diet, be randomized, self-weight, track diet, and report physical activity minutes
• physician approval to participate

Exclusion Criteria

• history of type 1 diabetes or type 2 diabetes
• use of anti-obesity medications or participation in another weight loss program or intervention
• use of glucose lowering medications other than metformin
• pregnant or planning to become pregnant during the intervention period
• breastfeeding
• use of oral corticosteroids
• previous bariatric surgery or planning to have bariatric surgery during the study period
• blood disorders that influence HbA1c, including frequent blood transfusions, phlebotomy, anemia, hemoglobinopathy, polycythemia
• any condition for which the study team deems participation to be unsafe or inappropriate
• inability to read, write, or speak English
• inability to provide informed consent
• adherence to a vegan or vegetarian diet
• adherence to a very low-carbohydrate (keto) diet
• difficulty chewing or swallowing
• no influence over what foods are purchased, prepared, and/or served
• above weight limit for DEXA (500 pounds)
• untreated eating disorder or mental health conditions, such as depression with suicidal ideation, bipolar or schizophrenia with psychosis
• use of warfarin
• chronic kidney disease, stage 4 or higher
• use of loop diuretics: 20mg or higher of furosemide or equivalent (Lasix (furosemide), Bumex (bumetanide), Ederin or Sodium Edecrin (ethacrynic acid), Demadex or Soaanz (torsemide))
• any concerning values in baseline labs (participants will be referred to Primary Care Physician and will be allowed to return for later enrollment if labs are no longer concerning)

• Triglycerides 600 Milligrams per deciliter (mg/dL) or higher
• Thyroid stimulating hormone of any abnormal value
• Potassium of any abnormal value

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Laura Saslow

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laura Saslow, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

References

Griauzde DH, O'Brien A, Yancy WS Jr, Richardson CR, Krinock J, DeJonckheere M, Isaman DJM, Vanias K, Shopinski S, Saslow LR. 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. Trials. 2022 Sep 30;23(1):827. doi: 10.1186/s13063-022-06770-3.

Reference Type: DERIVED

PMID: 36176003 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

R01DK125792-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00196546

Identifier Type: -

Identifier Source: org_study_id