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Trial record 1 of 2 for:    10496449 [PUBMED-IDS]
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Plant-Based Dietary Intervention in Type 2 Diabetes-2 (WCCR-DIAB2)

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ClinicalTrials.gov Identifier: NCT01931631
Recruitment Status : Suspended (Erroneously duplicated study)
First Posted : August 29, 2013
Last Update Posted : April 10, 2018
Sponsor:
Collaborator:
George Washington University
Information provided by (Responsible Party):
Physicians Committee for Responsible Medicine

Brief Summary:
The purpose of the study is to assess whether, in individuals with type 2 diabetes, a low-fat, vegan diet improves blood glucose control more effectively than a control diet based on current American Diabetes Association (ADA) guidelines. The principal measure is hemoglobin A1c. Cardiovascular risk factors and dietary acceptability are also assessed. The study duration is 20 weeks with a one-year follow-up.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Behavioral: Low-fat, low-Glycemic Index, vegan diet Behavioral: ADA diet Not Applicable

Detailed Description:
Preliminary evidence suggests that low-fat, vegetarian regimens similar to those used to reverse coronary artery blockages may have a significant beneficial effect on type 2 diabetes, as demonstrated by reductions in fasting serum glucose concentrations and medication use. The investigators therefore randomly assigned 99 individuals with type 2 diabetes to either a low-fat, vegan diet or a diet based on current American Diabetes Association guidelines for 22 weeks with a one-year follow-up period. The principal dependent measure is hemoglobin A1c. Cardiovascular risk factors are also being tracked, as is dietary acceptance.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Practice-Based, Nutrition Intervention in Type 2 Diabetes
Study Start Date : January 2014
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low-fat, low-Glycemic Index, vegan diet
Low-fat, low-Glycemic Index, vegan diet
Behavioral: Low-fat, low-Glycemic Index, vegan diet
Low-fat, low-Glycemic Index, vegan diet

Active Comparator: ADA diet
American Diabetes Association diet
Behavioral: ADA diet
Diet in accordance with the American Diabetes Association




Primary Outcome Measures :
  1. Hemoglobin A1c [ Time Frame: 20 weeks ]

Secondary Outcome Measures :
  1. Body Weight [ Time Frame: 20 Weeks ]
  2. Blood Pressure [ Time Frame: 20 Weeks ]
  3. Glucose [ Time Frame: 20 Weeks ]
  4. Comprehensive Metabolic Panel [ Time Frame: 20 Weeks & one-year follow up ]
  5. Serum cholesterol and triacylglycerol concentrations [ Time Frame: 20 Weeks ]
  6. Urinary albumin and creatinine [ Time Frame: 20 Weeks ]
  7. Genotyping for Taq1 A and Taq1 B polymorphisms, and APOE (Apolipoprotein E) [ Time Frame: 20 Weeks ]
  8. Waist and hip circumference [ Time Frame: 20 Weeks ]
  9. Dietary Acceptability [ Time Frame: 20 Weeks ]
  10. 3-day dietary records [ Time Frame: 20 Weeks ]
  11. International Physical Activity Questionnaire [ Time Frame: 20 Weeks ]
  12. Food Acceptability Questionnaire [ Time Frame: 20 Weeks ]
  13. Eating Inventory [ Time Frame: 20 Weeks ]
  14. CESD-R (Center for Epidemiologic Studies Depression Scale: Review and revision) [ Time Frame: 20 Weeks ]
  15. Beck Depression Inventory II (BDI-II) [ Time Frame: 20 Weeks ]


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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:

  • Diagnosis of Type 2 Diabetes Mellitus

Exclusion Criteria:

- hemoglobin A1c values <6.5% or >10.5% use of insulin for > 5 years tobacco use within the preceding 6 months consumption of more than 2 alcoholic beverages per day current drug abuse pregnancy unstable medical status current use of a low-fat, vegetarian diet.


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): NCT01931631


Locations
United States, District of Columbia
Physicians Committee for Responsible Medicine
Washington, District of Columbia, United States, 20016
Sponsors and Collaborators
Physicians Committee for Responsible Medicine
George Washington University
Investigators
Principal Investigator: Joshua Cohen, MD George Washington University

Publications:
Responsible Party: Physicians Committee for Responsible Medicine
ClinicalTrials.gov Identifier: NCT01931631     History of Changes
Other Study ID Numbers: PCRM GWU DM Study-2
First Posted: August 29, 2013    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: This study has been suspended

Keywords provided by Physicians Committee for Responsible Medicine:
Diabetes Mellitus, Type 2
Diet, Vegetarian
Diet, Fat-Restricted
Glycemic Index

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases