About this trial
Women with Polycystic Ovary Syndrome (PCOS) have high testosterone levels which is associated with altered insulin-glucose metabolism and an adverse blood lipid profile, predisposing them to the development of Type II Diabetes and Cardiovascular Disease (CVD). This study will investigate the use of dietary fish oil supplementation as a safe and effective intervention, and as an adjunct therapy to standard of care treatment with metformin to improve heart health, blood lipids and insulin-glucose metabolism in women with PCOS, and those with PCOS and Type 2 Diabetes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
diagnosis of PCOS
overweight-obese (BMI >25 kg/m2)
elevated fasting plasma TG (>150 mg/dL)
and/or apoB48-remnant cholesterol lipoproteins (>20 ug/ml)
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Fish oil
Dietary supplementFor 12 months
Metformin
Drug12 months
Fish Oil and Metformin
Combination product12 months
Treatment groups
Trial outcomes
Primary outcomes
Carotid intimal medial thickness
mm
carotid plaque height
mm
Left ventricular global longitudinal strain (LVGLS)
percent change in LVGLS
Secondary outcomes
Blood lipids
TG, LDL-C, HDL-C, non-HDL-C mmol/l
ApoB-lipoproteins
apob48 and apoB100 mg/l
remnant-cholesterol
mmol/l
Testosterone
nmol/l
Sponsors and contacts
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University of Alberta
Lead sponsor
Heart and Stroke Foundation of Canada
Collaborator