Botanical Oil Supplementation in Diabetic and Metabolic Syndrome Subjects
Status: | Completed |
---|---|
Conditions: | Endocrine, Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 21 - Any |
Updated: | 12/27/2018 |
Start Date: | May 2009 |
End Date: | March 2011 |
Modulation of Biomarkers and Gene Expression by Botanical Oil Supplementation in Diabetic and Metabolic Syndrome Subjects.
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.
inflammation compared to fish oils and placebo oil in subjects that are diabetic or have
metabolic syndrome.
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
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