Status:
COMPLETED
Effect of High Monounsaturated Fat Diet on Glycemic Control and Cardiovascular Risk Factors in Type 2 Diabetes
Lead Sponsor:
University of Cincinnati
Collaborating Sponsors:
American Diabetes Association
Conditions:
Overweight
Obesity
Eligibility:
All Genders
30-75 years
Phase:
PHASE1
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, pl...
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 d...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT00622960
Start Date
April 1 2004
End Date
April 1 2007
Last Update
February 25 2008
Active Locations (1)
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1
University of Cincinnati
Cincinnati, Ohio, United States, 45221