The Lifestyle Education About Prediabetes (Leap) Study

Not Applicable

Active, not recruiting

• Conditions: PreDiabetes
• Interventions: Behavioral: Very low-carbohydrate diet; Behavioral: Standard NDPP

• Registration Number: NCT05235425
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-02
• Study First Submitted QC: 2022-02-02
• Study First Posted: 2022-02-11
• Study Start: 2022-03-20
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-14
• Primary Completion: 2025-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Very low-carbohydrate diet (VLCD)	Very low-carbohydrate diet	VLCD is an adaptation of the standard NDPP curriculum, which preserves all features with the exception of altered dietary advice.
Standard NDPP	Standard NDPP	12-month long, calorie-restricted NDPP

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	0 to 12 months	HbA1c levels will be measured by standard immunoturbidimetric assay methods and quality control measures at a Clinical Laboratory Improvement Amendments (CLIA) certified lab.

Secondary Outcome Measures

Name	Time	Method
Change in high-density lipoproteins (HDL)	0 to 12 months
Change in HbA1c	0 to 4 months	HbA1c levels will be measured by standard immunoturbidimetric assay methods and quality control measures at a Clinical Laboratory Improvement Amendments (CLIA) certified lab.
Change in Inflammation based on C-reactive protein (CRP)	0 to 12 months	High-sensitivity C-reactive protein will be measured with nephelometric methods utilizing latex particles coated with CRP monoclonal antibodies and standardized against a CRP reference preparation.
Change in percent body weight loss	0-12 months
Change in small particle low-density lipoproteins (LDL)	0 to 12 months
Change in glycemic variability	0 to 12 months	This will be measured with an Abbott Libre Pro continuous glucose monitoring device on participants upper arm and the information on the sensor is blinded to participants.; The monitoring device will record participants' glucose levels in the interstitial fluid by a glucose oxidase method every 15 minutes, continuously for 14 days at each time point. T; The glucose variability and the proportion of time spent in the euglycemic (3-7.8 millimoles per litre (mmol/l)) and hyperglycemic (≥ 11.1 mmol/l for at least 15 minutes) states, following previous standards for interstitial glucose concentrations.
Change in triglycerides	0 to 12 months

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States