Status:
COMPLETED
Does a Low-Fat Vegetarian Diet Improve Insulin Resistance in Individuals With Type 2 Diabetes?
Lead Sponsor:
Institute for Clinical and Experimental Medicine
Conditions:
Insulin Resistance
Eligibility:
All Genders
30-70 years
Phase:
PHASE1
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 ...
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-fa...
Eligibility Criteria
Inclusion
- 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)
- Concurrent T2 DM therapy: The use of oral hypoglycemic medication stable for the last 3 months
- HbA1c ≥ 4 and ≤ 9.0 % (IFCC) \~ ≥ 6.0 and ≤ 11 % (DCCT)
- Men and women who are 30 to 70 years of age
- Body Mass Index (kg/m2) between 25 and 53
- Informed Consent: a signed and dated written consent obtained from the subject before any procedures are performed
- Willing to change dietary habits and to follow the prescribed diet and exercise program
Exclusion
- Current alcohol or drug abuse
- Pregnancy, lactating
- Unstable medical status
- Diagnosis of Type 1 diabetes mellitus
- Significant weight gain or loss (defined as ≥ 10% of total body weight) within the past 3 months prior to screening.
- Pacemaker or metal in the body.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00883038
Start Date
July 1 2008
End Date
March 1 2009
Last Update
April 17 2009
Active Locations (1)
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1
Institute for Clinical and Experimental Medicine
Prague, Czechia