Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
22 participants
INTERVENTIONAL
2017-09-11
2018-11-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Novel strategies to help participants achieve DPP weight-loss goals are important for two key reasons. First, weight loss is the primary driver of T2DM risk reduction, and the potential population health impact of the intervention is diminished when participants do not lose weight. Second, a growing number of health plans including Medicare offer coverage for the DPP and proposed reimbursement is largely tied to weight loss of at least 5 percent at 6 months and 12 months. The DPP costs approximately $400-$500 per participant per year. Unfortunately, organizations that offer the DPP may be reimbursed for much less than this if participants do not meet weight loss goals, which could significantly compromise the program's long-term financial sustainability.
One promising approach to help DPP participants lose more weight may be through a low-carbohydrate (LC) dietary intervention. Consistent with United States Dietary Guidelines (USDG), the original DPP Trial and translational group-based curricula recommend a low-fat (LF), calorie-restricted diet. However, there is growing controversy regarding the scientific merit of the Dietary Guidelines as well as growing recognition that LC diets may be more effective than LF diets for short-term weight loss and long-term weight maintenance. Notably, weight loss occurs without calorie restriction and LC diets improve blood glucose levels among individuals with T2DM and insulin resistance. Thus, a LC dietary intervention for prediabetes may augment individual weight loss and T2DM risk reduction while also maximizing third-party reimbursement.
The aim of this mixed methods pilot study is to test whether a LC-DPP may lead to greater weight loss than the original DPP. In addition to objective measures of this program's preliminary efficacy (e.g. weight, HbA1c) the study team will also obtain qualitative participant feedback on the intervention. Taken together, these data will be used to improve the curriculum and inform a larger-scale intervention.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Low-Carbohydrate Diabetes Prevention Program
At least 20 individuals with prediabetes will participate in a year-long , group-based program.
Low-Carbohydrate Diabetes Prevention Program
LC-DPP participants will be instructed to follow ad-libitum very low-carbohydrate, ketogenic diet, which restricts carbohydrate intake (not including fiber) to 20-35 grams per day with the goal of achieving nutritional ketosis. Participants will be encouraged to eat a normal amount of protein (roughly 80-120 grams per day) and to derive the remaining calories from fat. Allowable foods include: meats, fish, poultry, eggs, cheese, seeds, nuts, leafy greens, non-starchy vegetables, and some fruits.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Low-Carbohydrate Diabetes Prevention Program
LC-DPP participants will be instructed to follow ad-libitum very low-carbohydrate, ketogenic diet, which restricts carbohydrate intake (not including fiber) to 20-35 grams per day with the goal of achieving nutritional ketosis. Participants will be encouraged to eat a normal amount of protein (roughly 80-120 grams per day) and to derive the remaining calories from fat. Allowable foods include: meats, fish, poultry, eggs, cheese, seeds, nuts, leafy greens, non-starchy vegetables, and some fruits.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. HbA1c between 5.7-6.4% drawn within 6 months of the study start date
3. Willingness to participate in group-based classes
4. Able to engage in at least light physical activities such as walking.
Exclusion Criteria
2. Current participation in another lifestyle or behavior change program or research study
3. Vegetarian or vegan lifestyle
4. History of bariatric surgery
5. Inability to read, write, or speak English
6. Inability to provide informed consent
7. Women who are pregnant or intend to become pregnant during the intervention period.
8. Insured by Premier Care or Grad Care; these individuals have the opportunity to participate in a standard DPP, which is offered as a covered benefit through their health plan.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Kidney Foundation, United States
OTHER
University of Michigan
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dina Griauzde, Internal Medicine
Clinical Lecturer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Michigan Medicine
Ann Arbor, Michigan, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Hafez Griauzde D, Saslow L, Patterson K, Ansari T, Liestenfeltz B, Tisack A, Bihn P, Shopinski S, Richardson CR. Mixed methods pilot study of a low-carbohydrate diabetes prevention programme among adults with pre-diabetes in the USA. BMJ Open. 2020 Jan 21;10(1):e033397. doi: 10.1136/bmjopen-2019-033397.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
F046400
Identifier Type: -
Identifier Source: org_study_id