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

This study has been completed.
Sponsor:
Collaborator:
American Diabetes Association
Information provided by:
University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00622960
First received: February 13, 2008
Last updated: February 22, 2008
Last verified: February 2008
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of High Monounsaturated Fat and High Carbohydrate Diets on Glycemic Control and Cardiovascular Risk Factors in Type 2 Diabetes

Resource links provided by NLM:


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
Experimental: High MUFA diet
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.
Active Comparator: High CHO diet
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided by University of Cincinnati

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bonnie J. Brehm, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00622960     History of Changes
Other Study ID Numbers: ADA 1-04-CR-05
Study First Received: February 13, 2008
Last Updated: February 22, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Cincinnati:
obesity
type 2 diabetes
weight loss
monounsaturated fat
diet

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Overweight
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014