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

NCT ID: NCT00622960

Last Updated: 2008-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2007-04-30

Brief Summary

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.

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.

Conditions

Overweight; Obesity; Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

High MUFA diet

Those subjects assigned to a high monounsaturated fat diet

Group Type: EXPERIMENTAL

High-MUFA diet

Intervention Type: OTHER

The effects of high monounsaturated fat diet on body weight, body composition, lipid profile, and glycemic control.

High CHO diet

Those subjects assigned to a high carbohydrate diet

Group Type: ACTIVE_COMPARATOR

High-CHO diet

Intervention Type: OTHER

The effects of high carbohydrate diet on body weight, body composition, lipid profile, and glycemic control.

Interventions

High-MUFA diet

The effects of high monounsaturated fat diet on body weight, body composition, lipid profile, and glycemic control.

Intervention Type: OTHER

High-CHO diet

The effects of high carbohydrate diet on body weight, body composition, lipid profile, and glycemic control.

Intervention Type: OTHER

Eligibility 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).

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Diabetes Association

OTHER

Sponsor Role: collaborator

University of Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

University of Cincinnati

Principal Investigators

Bonnie J Brehm, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

University of Cincinnati

Cincinnati, Ohio, United States

Countries

United States

References

Brehm BJ, Lattin BL, Summer SS, Boback JA, Gilchrist GM, Jandacek RJ, D'Alessio DA. One-year comparison of a high-monounsaturated fat diet with a high-carbohydrate diet in type 2 diabetes. Diabetes Care. 2009 Feb;32(2):215-20. doi: 10.2337/dc08-0687. Epub 2008 Oct 28.

Reference Type: DERIVED

PMID: 18957534 (View on PubMed)

Other Identifiers

ADA 1-04-CR-05

Identifier Type: -

Identifier Source: org_study_id