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

University of Michigan

Status: Completed

Conditions: PreDiabetes

Treatments: Behavioral: Standard NDPP; Behavioral: Very low-carbohydrate diet

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05235425

R01DK125792-01A1 (U.S. NIH Grant/Contract)

HUM00196546

Details and patient eligibility

About

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.

Enrollment: 304 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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304 participants in 2 patient groups

Standard NDPP

Active Comparator group

Description:

12-month long, calorie-restricted NDPP

Treatment:

Behavioral: Standard NDPP

Very low-carbohydrate diet (VLCD)

Experimental group

Description:

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

Treatment:

Behavioral: Very low-carbohydrate diet