Status:
COMPLETED
Metabolic Actions of Omega-3 Fatty Acids
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
National Institutes of Health (NIH)
US Department of Veterans Affairs
Conditions:
Metabolic Syndrome
Eligibility:
All Genders
25-80 years
Phase:
NA
Brief Summary
The metabolic syndrome raises the risk of heart disease and is currently at epidemic proportions in the U.S. It consists of 3 of the following components: central obesity, high triglycerides, low HDL,...
Detailed Description
Metabolic Actions of Omega-3 Fatty Acids on Inflammation and Adipocyte Lipolysis in the Metabolic Syndrome Epidemiological studies identify metabolic syndrome (MetS) as a biomarker of cardiovascular ...
Eligibility Criteria
Inclusion
- Metabolic Syndrome, including 2 of the following:
- Treated Hyperlipidemia or Untreated Triglycerides \> 150 mg/dL
- Waist circumference (inches) \> 35 (women) or \>40 (men)
- And at least 1 additional factor:
- Treated Hypertension or Untreated Blood pressure \>130/85 and \< 160/100 mm Hg
- HDL-C \< 40 mg/dL men \< 50 mg/dL women
- Glucose \> 100mg/dL and HbA1c \< 6.1%
Exclusion
- Fasting TG \> 500 mg/dL or LDL \> 180 mg/dL
- Fasting glucose\> 125 mg/dL or history of diabetes mellitus
- Hematologic or malignant disorders
- 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
- Clinical depression (per PI evaluation)
- Immunosuppressive or other therapy that would interfere with research testing
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2016
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01896414
Start Date
July 1 2014
End Date
May 30 2016
Last Update
January 14 2020
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
2
Amish Research Center
Lancaster, Pennsylvania, United States, 17601