Clinical trial NCT05235425: The Lifestyle Education About Prediabetes (Leap) Study
Official title: Testing a Very Low-carbohydrate Diet Version of the Diabetes Prevention Program to Reduce Risk Factors for Type 2 Diabetes: The LEAP (Lifestyle Education About Prediabetes) Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: PreDiabetes
Keywords: Very low carbohydrate diet
Diabetes Prevention Program
Nutrition therapy
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2022-02-11
Enrollment: 300
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in HbA1c
timeFrame: 0 to 12 months
Secondary outcomes:
measure: Change in Inflammation based on C-reactive protein (CRP)
timeFrame: 0 to 12 months
measure: Change in percent body weight loss
timeFrame: 0-12 months
measure: Change in glycemic variability
timeFrame: 0 to 12 months
measure: Change in small particle low-density lipoproteins (LDL)
timeFrame: 0 to 12 months
measure: Change in high-density lipoproteins (HDL)
timeFrame: 0 to 12 months
measure: Change in triglycerides
timeFrame: 0 to 12 months
measure: Change in HbA1c
timeFrame: 0 to 4 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Laura Saslow, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.