Clinical Trials Logo

Clinical Trial Summary

The investigators will conduct a single-arm mixed methods pilot study to estimate weight loss as well as the percentage of participants who achieve 5% weight loss in a 16-week, Low-Carbohydrate Diabetes Prevention Program (LC-DPP). Weight loss from the pilot LC-DPP cohort will be compared to weight loss outcomes from previously published DPP studies. The investigators will also evaluate secondary outcomes including change in physical activity, mental health, psychosocial functioning, and hemoglobin A1c over the 6-month study period.


Clinical Trial Description

An estimated 86 million US adults are have prediabetes, and, without intervention, many will develop T2DM over time. Fortunately, T2DM can be prevented or delayed through modest lifestyle changes. The landmark Diabetes Prevention Program (DPP) Trial demonstrated a 58 percent reduction in the 3-year incidence of T2DM among individuals with prediabetes who achieved 7 percent body weight loss and engaged in routine physical activity. Accordingly, the DPP lifestyle intervention has been translated to communities across the United States, and, on average, participant weight change is 4 percent at 12 months. Thus, while group-based DPPs and can effectively promote weight loss among some participants, many DPP participants do not achieve the program goal of 5 to 7 percent body weight loss.

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03258918
Study type Interventional
Source University of Michigan
Contact
Status Completed
Phase N/A
Start date September 11, 2017
Completion date November 7, 2018

See also
  Status Clinical Trial Phase
Recruiting NCT05354245 - Using a Complex Carbohydrate Mixture to Steer Fermentation and Improve Metabolism in Adults With Overweight and Prediabetes (DISTAL) N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT06115265 - Ketogenic Diet and Diabetes Demonstration Project N/A
Completed NCT03188263 - Morning Light Treatment to Improve Glucose Metabolism N/A
Recruiting NCT03821961 - 18F-FDOPA PET/CT Imaging in Patients Undergoing Metabolic Surgery N/A
Completed NCT04303468 - Intervention With a GABA Supplement in Prediabetics N/A
Recruiting NCT06094231 - Treating Patients With Renal Impairment and Altered Glucose MetAbolism With TherapeutIc Carbohydrate Restriction and Sglt2-Inhibiton - a Pilot Study N/A
Completed NCT03675360 - Low-Carbohydrate Dietary Pattern on Glycemic Outcomes Trial N/A
Completed NCT01910051 - Explorative Assessment of Biomarkers in Overweight and Obese Subjects
Completed NCT03527368 - The Time-Restricted Intake of Meals Study N/A
Suspended NCT03240978 - Exercise Intervention for the Prevention of Prediabetes in Overweight Chinese N/A
Completed NCT03865342 - Prevention of Diabetes Using Mobile-enabled, Virtual Delivery of the National Diabetes Prevention Program N/A
Completed NCT02899390 - Diabetes Prevention Program in Adults of the Yaqui Tribe of Hermosillo, Sonora at Risk of Diabetes N/A
Recruiting NCT01972113 - Vitamin K and Glucose Metabolism in Children at Risk for Diabetes (Vita-K 'n' Kids Study) N/A
Completed NCT01432509 - Prospective Follow-up of a Cohort of Pre-diabetics in the North of France (DiabeNord) N/A
Completed NCT01436916 - Oral Cholecalciferol in Prevention of Type 2 Diabetes Mellitus Phase 4
Completed NCT00990184 - Study to Evaluate the Effects of Colesevelam on Insulin Sensitivity and ß-Cell Function in Subjects With Impaired Fasting Glucose (Prediabetes) Phase 3
Completed NCT00886340 - A Lifestyle Change Program to Prevent Type 2 Diabetes Phase 2
Not yet recruiting NCT05658770 - Efficacy of Physical Exercise on Glucose Control in People With Prediabetes (GLYCEX) - Phase II N/A