Effect of High Monounsaturated Fat Diet on Glycemic Control and Cardiovascular Risk Factors in Type 2 Diabetes
Completed · Phase 1
Conditions studied: Overweight, Obesity, Type 2 Diabetes
In brief
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.
Key facts
- Study ID
- NCT00622960
- Run by
- University of Cincinnati
- People needed
- 124
- Starts
- 2004-04-01
- Expected to finish
- 2007-04-01
- Last updated by the study team
- 2008-02-25
Who can join
Age: 30 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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).
Where it is running
- University of Cincinnati — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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