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

February 22, 2008 updated by: University of Cincinnati

Comparison of High Monounsaturated Fat and High Carbohydrate Diets on Glycemic Control and Cardiovascular Risk Factors in Type 2 Diabetes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
body weight
Time Frame: prior to and after 4, 8, and 12 months of dieting
prior to and after 4, 8, and 12 months of dieting

Secondary Outcome Measures

Outcome Measure
Time Frame
body fat
Time Frame: prior to and after 4, 8, and 12 months of dieting
prior to and after 4, 8, and 12 months of dieting
blood pressure
Time Frame: prior to and after 4, 8, and 12 months of dieting
prior to and after 4, 8, and 12 months of dieting
blood lipid profile
Time Frame: prior to and after 4, 8, and 12 months of dieting
prior to and after 4, 8, and 12 months of dieting
glycemic control (glucose, insulin, and HbA1c)
Time Frame: prior to and after 4, 8, and 12 months of dieting
prior to and after 4, 8, and 12 months of dieting

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cincinnati

Collaborators

American Diabetes Association

Investigators

  • Principal Investigator: Bonnie J Brehm, PhD, University of Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

February 13, 2008

First Submitted That Met QC Criteria

February 22, 2008

First Posted (Estimate)

February 25, 2008

Study Record Updates

Last Update Posted (Estimate)

February 25, 2008

Last Update Submitted That Met QC Criteria

February 22, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADA 1-04-CR-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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