Status:
COMPLETED
Comparative Effects of 2 Diets in Veterans With the Metabolic Syndrome
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
University of Maryland
Conditions:
Metabolic Syndrome
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The purpose of the study is to examine the effects of 2 commonly used diets, a Mediterranean monounsaturated fatty acid enriched (MUFA) or AHA polyunsaturated (PUFA) enriched diet combined with the VA...
Detailed Description
The Metabolic Syndrome (MetS) is a common problem among Veterans and is associated with a greater likelihood of cardiovascular disease (CVD). The Mediterranean diet is the only popular diet that has b...
Eligibility Criteria
Inclusion
- Presence of 3 or more of the following):
- Waist circumference \>102 cm in men or \>88 cm women
- Treated Hypertension or Untreated Blood pressure \>130/85 and \< 160/100 mm Hg
- Treated Hyperglycemia or Untreated Fasting blood glucose (FBG) \>100 mg/dL (based on 2006 guidelines)
- Treated Hyperlipidemia or Untreated Triglycerides \> 150 mg/dL
- HDL-C \< 40 mg/dL men \< 50 mg/dL women
Exclusion
- Decompensated heart failure (NYHA Class IV);
- Severe Pulmonary disease (Unable to walk on a treadmill at 2.5 mph or greater);
- Chronic renal insufficiency (Cr \> 2.5 mg/dL)
- Treated diabetes mellitus with FBG \> 180 mg/dL or HbA1C \>9g %
- Hematologic or malignant disorders
- Treated SBP \>160 mmHg and/or DBP \> 95 mmHg ;
- Treated TG \> 250 mg/dL
- Use of systemic vasodilators (e.g., nitrates)
- Morbid Obesity (BMI \> 50 kg/m2)
- Endocrine (thyroid) or metabolic disorders (unless treated and under control)
- Alcohol consumption greater than (2) 4-ounce glasses of table wine, (2) 12-oz bottles of beer or 2 shots of spirits in men or women
- Active IV drug abuse within the past 6 months
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00852475
Start Date
February 1 2010
End Date
December 1 2014
Last Update
February 2 2017
Active Locations (1)
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1
VA Maryland Health Care System, Baltimore
Baltimore, Maryland, United States, 21201