Status:
COMPLETED
The Lifestyle Education About Prediabetes (Leap) Study
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
PreDiabetes
Eligibility:
All Genders
21-75 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 14 2025
Estimated Enrollment :
304 Patients enrolled
Trial Details
Trial ID
NCT05235425
Start Date
March 20 2022
End Date
November 14 2025
Last Update
December 19 2025
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109