The Lifestyle Education About Prediabetes (Leap) Study

NCT05235425 | Completed

• 2 other identifiers: HUM00196546R01DK125792-01A1
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  HbA1c levels will be measured by standard immunoturbidimetric assay methods and quality control measures at a Clinical Laboratory Improvement Amendments (CLIA) certified lab.

  0 to 12 months

Secondary Outcomes (7)

• Change in Inflammation based on C-reactive protein (CRP)

  0 to 12 months

• Change in percent body weight loss

  0-12 months

• Change in glycemic variability

  0 to 12 months

• Change in small particle low-density lipoproteins (LDL)

  0 to 12 months

• Change in high-density lipoproteins (HDL)

  0 to 12 months

Study Arms (2)

Standard NDPP

ACTIVE COMPARATOR

12-month long, calorie-restricted NDPP

Behavioral: Standard NDPP

Very low-carbohydrate diet (VLCD)

EXPERIMENTAL

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

Behavioral: Very low-carbohydrate diet

Interventions

Standard NDPP 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.

Standard NDPP

Very low-carbohydrate diet 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.

Very low-carbohydrate diet (VLCD)

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• 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.

  PMID: 36176003 DERIVED

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Laura Saslow, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessment and data analysis will be masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 2, 2022
• First Posted: February 11, 2022
• Study Start: March 20, 2022
• Primary Completion: November 14, 2025
• Study Completion: November 14, 2025
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)