Back to resultsDoes a Low-Fat Vegetarian Diet Improve Insulin Resistance in Individuals With Type 2 Diabetes?
Primary Purpose
Insulin Resistance
Status
Completed
Phase
Phase 1
Locations
Czech Republic
Study Type
Interventional
Intervention
diabetic diet following the DNSG guidelines
low-fat vegetarian diet
Sponsored by
About this trial
This is an interventional treatment trial for Insulin Resistance focused on measuring insulin resistance, vegetarian diet
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Institute for Clinical and Experimental Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Active Comparator
Experimental
Arm Description
Diabetic diet following the DNSG guidelines
Low-fat vegetarian diet
Outcomes
Primary Outcome Measures
Insulin resistance
Secondary Outcome Measures
Visceral to subcutaneous fatty tissue ratio
Full Information
NCT ID
NCT00883038
First Posted
July 15, 2008
Last Updated
April 15, 2009
Sponsor
Institute for Clinical and Experimental Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00883038
Brief Title
Does a Low-Fat Vegetarian Diet Improve Insulin Resistance in Individuals With Type 2 Diabetes?
Official Title
Does a Low-Fat Vegetarian Diet Improve Insulin Resistance in Individuals With Type 2 Diabetes?
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Institute for Clinical and Experimental Medicine
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance
Keywords
insulin resistance, vegetarian diet
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active Comparator
Arm Type
Active Comparator
Arm Description
Diabetic diet following the DNSG guidelines
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Low-fat vegetarian diet
Intervention Type
Other
Intervention Name(s)
diabetic diet following the DNSG guidelines
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
low-fat vegetarian diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Insulin resistance
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Visceral to subcutaneous fatty tissue ratio
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terezie Pelikanova, MD, PhD
Organizational Affiliation
Head of the Diabetes Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Clinical and Experimental Medicine
City
Prague
Country
Czech Republic
12. IPD Sharing Statement
Citations:
PubMed Identifier
27107842
Citation
Kahleova H, Tonstad S, Rosmus J, Fisar P, Mari A, Hill M, Pelikanova T. The effect of a vegetarian versus conventional hypocaloric diet on serum concentrations of persistent organic pollutants in patients with type 2 diabetes. Nutr Metab Cardiovasc Dis. 2016 May;26(5):430-8. doi: 10.1016/j.numecd.2016.01.008. Epub 2016 Jan 28.
Results Reference
derived
PubMed Identifier
21480966
Citation
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.
Results Reference
derived
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Does a Low-Fat Vegetarian Diet Improve Insulin Resistance in Individuals With Type 2 Diabetes?
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