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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
Information provided by:

Study Description
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.

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

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Does a Low-Fat Vegetarian Diet Improve Insulin Resistance in Individuals With Type 2 Diabetes?
Study Start Date : July 2008
Primary Completion Date : November 2008
Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vegetarian Diet
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :
  1. Insulin resistance [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Visceral to subcutaneous fatty tissue ratio [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT00883038

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

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
First Posted: April 17, 2009    Key Record Dates
Last Update Posted: April 17, 2009
Last Verified: April 2009

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

Additional relevant MeSH terms:
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs