Botanical Oil Supplementation in Diabetic and Metabolic Syndrome Subjects

Completed · Phase 2

Conditions studied: Diabetes, Metabolic Syndrome x

In brief

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.

Key facts

Study ID

NCT01145066

Run by

Wake Forest University Health Sciences

People needed

80

Starts

2009-05-01

Expected to finish

2011-03-01

Last updated by the study team

2019-07-18

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.