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

Insulin Resistance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00883038
• Other study ID #: 785206
• Status: Completed
• Phase: Phase 1
• First received: July 15, 2008
• Last updated: April 15, 2009
• Start date: July 2008
• Est. completion date: March 2009

Study information

• Verified date: April 2009
• Source: Institute for Clinical and Experimental Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insulin Resistance

Intervention

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.
• 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.

Locations

Country	Name	City	State
Czech Republic	Institute for Clinical and Experimental Medicine	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Institute for Clinical and Experimental Medicine

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin resistance		6 months	Yes
Secondary	Visceral to subcutaneous fatty tissue ratio		6 months	Yes