The Lifestyle Education About Prediabetes (Leap) Study (LEAP)

  • STATUS
    Recruiting
  • End date
    Jul 27, 2025
  • participants needed
    300
  • sponsor
    University of Michigan
Updated on 27 July 2022
hemoglobin a1c
diabetes prevention

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.

Details
Condition PreDiabetes
Treatment Standard NDPP, Very low-carbohydrate diet
Clinical Study IdentifierNCT05235425
SponsorUniversity of Michigan
Last Modified on27 July 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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