Text Size

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
History of Changes
  Purpose

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.


Condition Intervention Phase
Insulin Resistance
 Other: diabetic diet following the DNSG guidelines
Other: low-fat vegetarian diet
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Does a Low-Fat Vegetarian Diet Improve Insulin Resistance in Individuals With Type 2 Diabetes?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institute for Clinical and Experimental Medicine:

Primary Outcome Measures:
  • Insulin resistance [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Visceral to subcutaneous fatty tissue ratio [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 70
Study Start Date: July 2008
Study Completion Date: March 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active Comparator
Diabetic diet following the DNSG guidelines
 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.
Experimental: Experimental
Low-fat vegetarian diet
 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.

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.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00883038

Locations
Czech Republic
Institute for Clinical and Experimental Medicine
Prague, Czech Republic
Sponsors and Collaborators
Institute for Clinical and Experimental Medicine
Investigators
Principal Investigator: Terezie Pelikanova, MD, PhD Head of the Diabetes Center
  More Information

No publications provided by Institute for Clinical and Experimental Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dagmar Koveslygetyova, Institute for Clinical and Experimental Medicine
ClinicalTrials.gov Identifier: NCT00883038     History of Changes
Other Study ID Numbers: 785206
Study First Received: July 15, 2008
Last Updated: April 15, 2009
Health Authority: Czech Republic: Ethics Committee

Keywords provided by Institute for Clinical and Experimental Medicine:
insulin resistance
vegetarian diet

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Insulin Resistance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Hyperinsulinism
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013