Effect of High Monounsaturated Fat Diet on Glycemic Control and Cardiovascular Risk Factors in Type 2 Diabetes - Full Text View

Sponsors and Collaborators:	University of Cincinnati American Diabetes Association
Information provided by:	University of Cincinnati
ClinicalTrials.gov Identifier:	NCT00622960

Purpose

The purpose of this proposed randomized, controlled trial is to compare the effects of high monounsaturated fat diets and high carbohydrate diets on body weight, body composition, glycemic control, plasma lipids, and other cardiovascular risk factors over a period of one year. At present, no such studies of free-living subjects have been performed. The specific aims of the proposed project are to test the hypotheses that (1) a high monounsaturated fat diet will produce greater weight loss/body fat loss and more successful weight maintenance than a high carbohydrate diet and (2) a high monounsaturated fat diet will result in an improved lipid profile and better glycemic control than a high carbohydrate diet.

Condition	Intervention	Phase
Overweight Obesity Type 2 Diabetes	Other: High-MUFA diet Other: High-CHO diet	Phase I

MedlinePlus related topics: Diabetes Obesity Weight Control

Drug Information available for: Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Comparison of High Monounsaturated Fat and High Carbohydrate Diets on Glycemic Control and Cardiovascular Risk Factors in Type 2 Diabetes

Further study details as provided by University of Cincinnati:

Primary Outcome Measures:

body weight [ Time Frame: prior to and after 4, 8, and 12 months of dieting ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

body fat [ Time Frame: prior to and after 4, 8, and 12 months of dieting ] [ Designated as safety issue: No ]
blood pressure [ Time Frame: prior to and after 4, 8, and 12 months of dieting ] [ Designated as safety issue: No ]
blood lipid profile [ Time Frame: prior to and after 4, 8, and 12 months of dieting ] [ Designated as safety issue: No ]
glycemic control (glucose, insulin, and HbA1c) [ Time Frame: prior to and after 4, 8, and 12 months of dieting ] [ Designated as safety issue: No ]

Enrollment:	124
Study Start Date:	April 2004
Study Completion Date:	April 2007
Primary Completion Date:	April 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
High MUFA diet: Experimental Those subjects assigned to a high monounsaturated fat diet	Other: High-MUFA diet The effects of high monounsaturated fat diet on body weight, body composition, lipid profile, and glycemic control.
High CHO diet: Active Comparator Those subjects assigned to a high carbohydrate diet	Other: High-CHO diet The effects of high carbohydrate diet on body weight, body composition, lipid profile, and glycemic control.

Detailed Description:

The incidence of type 2 diabetes has increased steadily over the last three decades. Although medical nutrition therapy is an integral component of diabetes management, nutrition recommendations for diabetes have often been based on clinical experience and expert consensus, rather than on carefully controlled clinical trials. The expert consensus on medical nutrition therapy is that carbohydrate and monounsaturated fat together should provide approximately 60-70% of total energy intake. This recommendation accommodates parties on both sides of a debate over what constitutes the optimal macronutrient composition of a diet for type 2 diabetic patients. On one side are proponents of high carbohydrate, low fat diets who contend that this regimen promotes the lowering of total- and LDL-cholesterol and is less calorically dense than diets containing a higher percentage of fat. On the other side are advocates of high monounsaturated fat, Mediterranean-type diets who cite data from short-term studies indicating that this approach decreases postprandial levels of plasma glucose, insulin, and triglycerides, and increases HDL-cholesterol more than isocaloric high carbohydrate diets. However, there is concern about the potential for high fat diets to increase energy intake and weight gain among free-living subjects. To make definitive, scientifically-based diet recommendations, it is essential that controlled long-term trials be conducted to demonstrate the health effects of specific percentages of monounsaturated fats and carbohydrates in the diets of persons with type 2 diabetes.

Eligibility

Ages Eligible for Study:	30 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

BMI of 27-40 kg/m2
30-75 years of age
Stable body weight for the preceding 6 months
Diagnosis of type 2 diabetes for at least 6 months prior to enrollment
HbA1c of 6.5 to 9.0
Treatment by diet or oral agents only

Exclusion Criteria:

Pregnancy or lactation
Active cardiac, pulmonary, renal, liver, or gastrointestinal disease
Untreated thyroid disease or hypertension
Hypertriglyceridemia with levels of TG > 500 mg/dl
Use of insulin
Use of specific medications that may alter lipid or glucose metabolism (other than the statins)
Use of medications that commonly cause significant alterations in body weight (e.g., corticosteroids).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00622960

Locations

United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45221

Sponsors and Collaborators

University of Cincinnati

American Diabetes Association

Investigators

Principal Investigator:

Bonnie J Brehm, PhD

University of Cincinnati

More Information

Responsible Party:	University of Cincinnati ( Bonnie J. Brehm )
Study ID Numbers:	ADA 1-04-CR-05
Study First Received:	February 13, 2008
Last Updated:	February 22, 2008
ClinicalTrials.gov Identifier:	NCT00622960
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Cincinnati:

obesity
type 2 diabetes
weight loss
monounsaturated fat
diet

Study placed in the following topic categories:

Obesity
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Overweight
Body Weight
Signs and Symptoms

Diabetes Mellitus, Type 2
Weight Loss
Nutrition Disorders
Overnutrition
Endocrinopathy
Glucose Metabolism Disorders
Metabolic disorder

ClinicalTrials.gov processed this record on January 16, 2009