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

Primary Purpose

PreDiabetes

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard NDPP
Very low-carbohydrate diet
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PreDiabetes focused on measuring Very low carbohydrate diet, Diabetes Prevention Program, Nutrition therapy

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of MichiganRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard NDPP

Very low-carbohydrate diet (VLCD)

Arm Description

12-month long, calorie-restricted NDPP

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

Outcomes

Primary Outcome Measures

Change in HbA1c
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

Change in Inflammation based on C-reactive protein (CRP)
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
Change in glycemic variability
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 small particle low-density lipoproteins (LDL)
Change in high-density lipoproteins (HDL)
Change in triglycerides
Change in HbA1c
HbA1c levels will be measured by standard immunoturbidimetric assay methods and quality control measures at a Clinical Laboratory Improvement Amendments (CLIA) certified lab.

Full Information

First Posted
February 2, 2022
Last Updated
June 12, 2023
Sponsor
University of Michigan
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT05235425
Brief Title
The Lifestyle Education About Prediabetes (Leap) Study
Acronym
LEAP
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 20, 2022 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes
Keywords
Very low carbohydrate diet, Diabetes Prevention Program, Nutrition therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Outcome assessment and data analysis will be masked
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard NDPP
Arm Type
Active Comparator
Arm Description
12-month long, calorie-restricted NDPP
Arm Title
Very low-carbohydrate diet (VLCD)
Arm Type
Experimental
Arm Description
VLCD is an adaptation of the standard NDPP curriculum, which preserves all features with the exception of altered dietary advice.
Intervention Type
Behavioral
Intervention Name(s)
Standard NDPP
Intervention Description
Participants in this arm will be taught to manage their prediabetes with the Centers for Disease Control's standard National Diabetes Prevention Program. It teaches a lower calorie, lower fat diet. There will be a core phase and a maintenance phase of this study; the core phase will last for about 4 months and will involve weekly or every other week classes, home assignments, and brief check-in surveys. The maintenance phase will last for the remaining time, with classes and check-in surveys approximately once a month.
Intervention Type
Behavioral
Intervention Name(s)
Very low-carbohydrate diet
Intervention Description
Participants in this arm will be taught to manage their prediabetes with the Centers for Disease Control's National Diabetes Prevention Program, adapted to teach a very low-carbohydrate diet, also called a ketogenic or "keto" diet. This diet involves eating non-starchy vegetables, leafy greens, cheese, meats, berries, nuts, and seeds and avoiding starchy foods like pasta, bread, rice, beans, many fruits, etc. There will be a core phase and a maintenance phase of this study; the core phase will last for about 4 months and will involve weekly or every other week classes, home assignments, and brief check-in surveys. The maintenance phase will last for the remaining time, with classes and check-in surveys approximately once a month.
Primary Outcome Measure Information:
Title
Change in HbA1c
Description
HbA1c levels will be measured by standard immunoturbidimetric assay methods and quality control measures at a Clinical Laboratory Improvement Amendments (CLIA) certified lab.
Time Frame
0 to 12 months
Secondary Outcome Measure Information:
Title
Change in Inflammation based on C-reactive protein (CRP)
Description
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.
Time Frame
0 to 12 months
Title
Change in percent body weight loss
Time Frame
0-12 months
Title
Change in glycemic variability
Description
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.
Time Frame
0 to 12 months
Title
Change in small particle low-density lipoproteins (LDL)
Time Frame
0 to 12 months
Title
Change in high-density lipoproteins (HDL)
Time Frame
0 to 12 months
Title
Change in triglycerides
Time Frame
0 to 12 months
Title
Change in HbA1c
Description
HbA1c levels will be measured by standard immunoturbidimetric assay methods and quality control measures at a Clinical Laboratory Improvement Amendments (CLIA) certified lab.
Time Frame
0 to 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Saslow, PhD
Phone
734-764-7836
Email
saslowl@umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Saslow, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Saslow, PhD
Phone
734-764-7836
Email
leapstudy@med.umich.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36176003
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.
Results Reference
derived

Learn more about this trial

The Lifestyle Education About Prediabetes (Leap) Study

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