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

Primary Purpose

Overweight, Obesity, Type 2 Diabetes

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
High-MUFA diet
High-CHO diet
Sponsored by
University of Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring obesity, type 2 diabetes, weight loss, monounsaturated fat, diet

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • University of Cincinnati

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High MUFA diet

High CHO diet

Arm Description

Those subjects assigned to a high monounsaturated fat diet

Those subjects assigned to a high carbohydrate diet

Outcomes

Primary Outcome Measures

body weight

Secondary Outcome Measures

body fat
blood pressure
blood lipid profile
glycemic control (glucose, insulin, and HbA1c)

Full Information

First Posted
February 13, 2008
Last Updated
February 22, 2008
Sponsor
University of Cincinnati
Collaborators
American Diabetes Association
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1. Study Identification

Unique Protocol Identification Number
NCT00622960
Brief Title
Effect of High Monounsaturated Fat Diet on Glycemic Control and Cardiovascular Risk Factors in Type 2 Diabetes
Official Title
Comparison of High Monounsaturated Fat and High Carbohydrate Diets on Glycemic Control and Cardiovascular Risk Factors in Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Cincinnati
Collaborators
American Diabetes Association

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity, Type 2 Diabetes
Keywords
obesity, type 2 diabetes, weight loss, monounsaturated fat, diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High MUFA diet
Arm Type
Experimental
Arm Description
Those subjects assigned to a high monounsaturated fat diet
Arm Title
High CHO diet
Arm Type
Active Comparator
Arm Description
Those subjects assigned to a high carbohydrate diet
Intervention Type
Other
Intervention Name(s)
High-MUFA diet
Intervention Description
The effects of high monounsaturated fat diet on body weight, body composition, lipid profile, and glycemic control.
Intervention Type
Other
Intervention Name(s)
High-CHO diet
Intervention Description
The effects of high carbohydrate diet on body weight, body composition, lipid profile, and glycemic control.
Primary Outcome Measure Information:
Title
body weight
Time Frame
prior to and after 4, 8, and 12 months of dieting
Secondary Outcome Measure Information:
Title
body fat
Time Frame
prior to and after 4, 8, and 12 months of dieting
Title
blood pressure
Time Frame
prior to and after 4, 8, and 12 months of dieting
Title
blood lipid profile
Time Frame
prior to and after 4, 8, and 12 months of dieting
Title
glycemic control (glucose, insulin, and HbA1c)
Time Frame
prior to and after 4, 8, and 12 months of dieting

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bonnie J Brehm, PhD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45221
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18957534
Citation
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.
Results Reference
derived

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

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