The Lifestyle Education About Prediabetes (Leap) Study

Last updated: March 13, 2025
Sponsor: University of Michigan
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Diabetes And Hypertension

Diabetes Mellitus Types I And Ii

Diabetes (Pediatric)

Treatment

Very low-carbohydrate diet

Standard NDPP

Clinical Study ID

NCT05235425
HUM00196546
R01DK125792-01A1
  • Ages 21-75
  • All Genders

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.

Eligibility Criteria

Inclusion

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, andreport physical activity minutes

  • physician approval to participate

Exclusion

Exclusion Criteria:

  • history of type 1 diabetes or type 2 diabetes

  • use of anti-obesity medications or participation in another weight loss program orintervention

  • 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 studyperiod

  • 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 orinappropriate

  • 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 withsuicidal 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 PrimaryCare Physician and will be allowed to return for later enrollment if labs are nolonger concerning)

  • Triglycerides 600 Milligrams per deciliter (mg/dL) or higher

  • Thyroid stimulating hormone of any abnormal value

  • Potassium of any abnormal value

Study Design

Total Participants: 300
Treatment Group(s): 2
Primary Treatment: Very low-carbohydrate diet
Phase:
Study Start date:
March 20, 2022
Estimated Completion Date:
October 31, 2025

Connect with a study center

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

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