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A Low-Carbohydrate Diabetes Prevention Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03258918
Recruitment Status : Completed
First Posted : August 23, 2017
Last Update Posted : December 12, 2018
Sponsor:
Collaborator:
National Kidney Foundation of Michigan
Information provided by (Responsible Party):
Dina Griauzde, Internal Medicine, University of Michigan

Brief 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.

Condition or disease Intervention/treatment Phase
PreDiabetes Behavioral: Low-Carbohydrate Diabetes Prevention Program Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Mixed Methods Pilot Study of a Low-Carbohydrate Diabetes Prevention Program Among Individuals With Prediabetes
Actual Study Start Date : September 11, 2017
Actual Primary Completion Date : November 7, 2018
Actual Study Completion Date : November 7, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Arm Intervention/treatment
Experimental: Low-Carbohydrate Diabetes Prevention Program
At least 20 individuals with prediabetes will participate in a year-long , group-based program.
Behavioral: 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.




Primary Outcome Measures :
  1. Change in body weight per participant over the study period [ Time Frame: Baseline, 12 months ]
    Measured as percent body weight loss per participant

  2. Percentage of participants who achieve weight loss goal [ Time Frame: Baseline,12 months ]
    Measured as percentange of participants who achieve 5% total body weight loss


Secondary Outcome Measures :
  1. Change in self-reported weekly physical activity minutes [ Time Frame: Baseline, 12 months ]
    Participants will maintain a log of weekly physical activity minutes

  2. Change in physical activity measured using the International Physical Activity Questionnaire [ Time Frame: Baseline, 12 months ]
    Participants will complete this validated survey

  3. Change in food cravings measured using the Control of Eating Questionnaire [ Time Frame: Baseline, 12 months ]
    Participants will complete this validated survey

  4. Change in stress eating measured using the Palatable Eating Motives Scale [ Time Frame: Baseline, 12 months ]
    Participants will complete this validated survey

  5. Change in self-reported health measured using the Global Health PROMIS Questionnaire [ Time Frame: Baseline, 12 months ]
    Participants will complete this validated survey

  6. Change in autonomous motivation measured using the Treatment Self-Regulation Questionnaire [ Time Frame: Baseline, 12 months ]
    Participants will complete this validated survey

  7. Change in hemoglobin A1c [ Time Frame: Baseline, 12 months ]
    Measured using a laboratory blood draw

  8. Session attendance [ Time Frame: Baseline, 12 months ]
    Measured as the number of sessions attended per participant

  9. Study attrition [ Time Frame: Baseline, 12 months ]
    Number of participants lost to follow-up


Other Outcome Measures:
  1. Change in diet as assessed by qualitative review of foods logs [ Time Frame: Baseline, 12 months ]
    Participants will maintain weekly food logs

  2. Change in diet as assessed by response to survey questions [ Time Frame: Baseline, 12 months ]
    Participants will respond to exploratory survey questions about diet created by the study team.

  3. Change in physical symptoms [ Time Frame: Baseline, 12 months ]
    Participants will respond to exploratory survey questions about physical symptoms created by the study team.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Overweight, defined as BMI≥25 kg/m2 [31]
  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:

  1. History of type 1 diabetes or type 2 diabetes
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03258918


Locations
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United States, Michigan
Michigan Medicine
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
National Kidney Foundation of Michigan
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dina Griauzde, Internal Medicine, Clinical Lecturer, University of Michigan
ClinicalTrials.gov Identifier: NCT03258918    
Other Study ID Numbers: F046400
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prediabetic State
Glucose Intolerance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia