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

This study has been completed.
Sponsor:
Information provided by:
Institute for Clinical and Experimental Medicine
ClinicalTrials.gov Identifier:
NCT00883038
First received: July 15, 2008
Last updated: April 15, 2009
Last verified: April 2009

July 15, 2008
April 15, 2009
July 2008
November 2008   (final data collection date for primary outcome measure)
Insulin resistance [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00883038 on ClinicalTrials.gov Archive Site
Visceral to subcutaneous fatty tissue ratio [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Does a Low-Fat Vegetarian Diet Improve Insulin Resistance in Individuals With Type 2 Diabetes?
Does a Low-Fat Vegetarian Diet Improve Insulin Resistance in Individuals With Type 2 Diabetes?

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Insulin Resistance
  • 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.
  • 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
Kahleova H, Matoulek M, Malinska H, Oliyarnik O, Kazdova L, Neskudla T, Skoch A, Hajek M, Hill M, Kahle M, Pelikanova T. Vegetarian diet improves insulin resistance and oxidative stress markers more than conventional diet in subjects with Type 2 diabetes. Diabet Med. 2011 May;28(5):549-59. doi: 10.1111/j.1464-5491.2010.03209.x.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
March 2009
November 2008   (final data collection date for primary outcome measure)

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.
Both
30 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic
 
NCT00883038
785206
Yes
Dagmar Koveslygetyova, Institute for Clinical and Experimental Medicine
Institute for Clinical and Experimental Medicine
Not Provided
Principal Investigator: Terezie Pelikanova, MD, PhD Head of the Diabetes Center
Institute for Clinical and Experimental Medicine
April 2009

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