Status:
COMPLETED
Botanical Oil Supplementation in Diabetic and Metabolic Syndrome Subjects
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
Brigham and Women's Hospital
Conditions:
Diabetes
Metabolic Syndrome x
Eligibility:
All Genders
21+ years
Phase:
PHASE2
Brief Summary
This study will compare how well a combination of borage and echium oils will reduce inflammation compared to fish oils and placebo oil in subjects that are diabetic or have metabolic syndrome.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01145066
Start Date
May 1 2009
End Date
March 1 2011
Last Update
July 18 2019
Active Locations (1)
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1
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157