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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
304
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.
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.
University of Michigan
Ann Arbor, Michigan, United States
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.
Time frame: 0 to 12 months
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.
Time frame: 0 to 12 months
Change in percent body weight loss
Time frame: 0-12 months
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.
Time frame: 0 to 12 months
Change in small particle low-density lipoproteins (LDL)
Time frame: 0 to 12 months
Change in high-density lipoproteins (HDL)
Time frame: 0 to 12 months
Change in triglycerides
Time frame: 0 to 12 months
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.
Time frame: 0 to 4 months
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