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Does a Low-Fat Vegetarian Diet Improve Insulin Resistance in Individuals With Type 2 Diabetes?

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ClinicalTrials.gov Identifier: NCT00883038
Recruitment Status : Completed
First Posted : April 17, 2009
Last Update Posted : April 17, 2009
Sponsor:
Information provided by:
Institute for Clinical and Experimental Medicine

Tracking Information
First Submitted Date  ICMJE July 15, 2008
First Posted Date  ICMJE April 17, 2009
Last Update Posted Date April 17, 2009
Study Start Date  ICMJE July 2008
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2009)
Insulin resistance [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2009)
Visceral to subcutaneous fatty tissue ratio [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Does a Low-Fat Vegetarian Diet Improve Insulin Resistance in Individuals With Type 2 Diabetes?
Official Title  ICMJE Does a Low-Fat Vegetarian Diet Improve Insulin Resistance in Individuals With Type 2 Diabetes?
Brief Summary

The aim of the study is to evaluate the effect of experimental (vegetarian) diet compared to conventional diet with similar caloric restriction on insulin resistance, body weight and body composition in type 2 diabetic patients after 3 month diet program and additional 3 month diet program combined with intensive exercise.

Hypothesis: Greater improvement in insulin resistance, greater weight loss without compromising the body composition (subjects will lose fat preferentially to lean body mass) and differences in the fatty tissue metabolism will be found in the experimental (vegetarian) group compared to the control (conventional diet) group despite the similar advise on caloric restriction in both diets. The differences between the two groups will increase after an intensive physical exercise program.

Detailed Description Open randomized study. Individuals with type 2 diabetes (n=60) will be recruited through newspaper advertisements and through advertisements in the hospital. They will be randomly assigned to a low-fat vegetarian diet or a diet following the guidelines of the Study Group on Diabetes and Nutrition of the European Association for the Study of Diabetes (DNSG) (21) with similar caloric restriction (-500 kcal/d). The participants will be followed for 12 weeks and then for another 12 weeks with the addition of intensive physical exercise. All meals during the 6 months will be provided.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Condition  ICMJE Insulin Resistance
Intervention  ICMJE
  • Other: diabetic diet following the DNSG guidelines
    The DNSG diet consists of 15-20% protein, ≤7% saturated fat, 60-70% carbohydrate and monounsaturated fats, cholesterol ≤200 mg/day, fiber content 20-30g/day.
  • Other: low-fat vegetarian diet
    The low-fat vegetarian diet (~10% of energy from fat, 15% protein, and 75% carbohydrate, fiber content 40-50 g/day) consists of vegetables, fruits, grains, legumes and small amounts of nuts. Participants will be asked to avoid animal products and added fats and to favor low-glycemic index foods, such as beans and green vegetables.
Study Arms  ICMJE
  • Active Comparator: Active Comparator
    Diabetic diet following the DNSG guidelines
    Intervention: Other: diabetic diet following the DNSG guidelines
  • Experimental: Experimental
    Low-fat vegetarian diet
    Intervention: Other: low-fat vegetarian diet
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 15, 2009)
70
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Individuals with type 2 diabetes as defined by the criteria of the American Diabetes Association and recognized by WHO, Expert Committee on the Diagnosis and Classification of Diabetes Mellitus (19,20)
  2. Concurrent T2 DM therapy: The use of oral hypoglycemic medication stable for the last 3 months
  3. HbA1c ≥ 4 and ≤ 9.0 % (IFCC) ~ ≥ 6.0 and ≤ 11 % (DCCT)
  4. Men and women who are 30 to 70 years of age
  5. Body Mass Index (kg/m2) between 25 and 53
  6. Informed Consent: a signed and dated written consent obtained from the subject before any procedures are performed
  7. Willing to change dietary habits and to follow the prescribed diet and exercise program

Exclusion Criteria:

  1. Current alcohol or drug abuse
  2. Pregnancy, lactating
  3. Unstable medical status
  4. Diagnosis of Type 1 diabetes mellitus
  5. Significant weight gain or loss (defined as ≥ 10% of total body weight) within the past 3 months prior to screening.
  6. Pacemaker or metal in the body.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czech Republic
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00883038
Other Study ID Numbers  ICMJE 785206
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dagmar Koveslygetyova, Institute for Clinical and Experimental Medicine
Study Sponsor  ICMJE Institute for Clinical and Experimental Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Terezie Pelikanova, MD, PhD Head of the Diabetes Center
PRS Account Institute for Clinical and Experimental Medicine
Verification Date April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP