Status:
COMPLETED
Effects of Low and Moderate Fat Diets on Lipids, Inflammation and Vascular Reactivity in the Metabolic Syndrome
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Metabolic Syndrome X
Dyslipidemias
Eligibility:
All Genders
30-75 years
Phase:
NA
Brief Summary
The metabolic syndrome consists of five concurrent conditions which increase risk of heart disease, stroke, and diabetes. Persons with the metabolic syndrome usually have high triglyceride and low HDL...
Detailed Description
The Metabolic Syndrome is characterized by elevated insulin levels, excess body fat in the waist, and elevated levels of glucose and blood pressure, and dyslipidemia. Dyslipidemia in the Metabolic Syn...
Eligibility Criteria
Inclusion
- Metabolic Syndrome: individuals must have at least three of the following five criteria:
- Abdominal obesity greater than 90 cm in Asian men, greater than 102 cm in all other men, greater than 80 cm in Asian women, and greater than 88 cm in all other women
- Triglycerides greater than or equal to 150 mg/dL at two screening visits (Required for the purposes of this study, which focuses on the dyslipidemic phenotype)
- HDL cholesterol levels less than 40 mg/dL in men and less than 50 mg/dL in women
- Blood pressure levels greater than 130/85 mmHg or taking an allowed blood pressure medication at Visit 1 (see definition in exclusions below)
- Fasting glucose greater than or equal to 100mg/dL at Visit 1
Exclusion
- LDL greater than or equal to 190 mg/dL
- Triglycerides greater than 500mg/dL at Visit 1
- Blood pressure over a mean of 150/95 at the two first visits
- Body mass index greater than 40 kg/m²
- Currently taking any lipid lowering medication other than statins
- Currently taking high doses of thiazide diuretics (greater than 50mg/day), or any other blood pressure medication in the past 4 weeks
- Use of plant sterols from sources such as Benecol or Take Control margarines in the past 4 weeks
- Use of any fish oil supplements in the week prior to screening
- Blood glucose greater than 140 mg/dL or use of diabetes medications
- Hospitalization for coronary disease in the last 6 months
- Use of nitroglycerin or other nitrates
- Unstable liver, renal, gastrointestinal or pulmonary disease or mental disease, or medically unstable for other reasons
- Alcohol intake greater than 2 drinks/day, any illegal drug use, smoking, chronic NSAID use or NSAID use within 5 days before the BAR study
- Pregnancy intended within one year or one year prior or currently lactating
- In reproductive age women, an irregular menstrual cycle (must have consistent menstrual cycle between 24 to 32 days)
- Use or expectation of use of oral or patch contraceptive
- Unable or unlikely to be able to comply with study requirements
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT00362908
Start Date
September 1 2006
End Date
June 1 2010
Last Update
October 28 2010
Active Locations (1)
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1
Northwest Lipid Research Clinic
Seattle, Washington, United States, 98104