Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:24 PM
Ignite Modification Date:
2025-12-24 @ 4:24 PM
NCT ID:
NCT01145066
Eligibility Criteria:
Inclusion Criteria:
* adults, aged 21 years or more with either diabetes or metabolic syndrome. metabolic syndrome defined by NCEP/ATPIII criteria; must have 3 out of 5 of the following risk factors: 1.central obesity, men-greater than or equal to 40 inches, women-greater than or equal to 35 inches; 2.fasting blood TG greater than or equal to 150mg/dl or be taking TG lowering medications; 3. blood HDL cholesterol, men less than 40 mg/dl, women less than 50 mg/dl; 4. blood pressure greater than or equal to 130/85 or on HTN medication 5. fasting glucose greater than or equal to 100 mg/dl.
* participants on statins or glucose lowering drugs if dosages are stable for 3 months
Exclusion criteria
* children/young adults less than 21 years of age
* currently using anti-inflammatory drugs including NSAIDS, oral/IV steroids or injection antiinflammatory drugs(for RA), aspirin greater than 100mg/day
* taking leukotriene receptor antagonists ( montelukast), tylenol or nasal/inhaled steroids OK.
* currently using niacin, fibrates or fish oil
* blood pressure greater than 170/100
* HB1Ac greater than 10%
* TG greater than 500 mg/dl
* myocardial infarction/vascular surgery/stroke within the past year
* any stage II,III,IV heart failure
* prior cholecystectomy
* end stage renal disease
* BMI less than 23 or greater than 45
* pregnancy
* alcohol use greater than 14 drinks per week
* current self reported tobacco or illicit drug use
* intolerance or allergy to fish oil
* participants taking insulin on QD or BID doses, stable for 3 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT01145066
Study Brief:
Protocol Section:
NCT01145066