Fish Oil, Metformin and Heart Health in PCOS

Recruiting now · Phase 1

Conditions studied: PCOS, Cardiovascular Disease, Atherosclerotic Cardiovascular Disease, Atherosclerotic Plaque, Cardiac Hypertrophy

In brief

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.

Key facts

Study ID

NCT06424860

Run by

University of Alberta

People needed

146

Starts

2025-11-01

Expected to finish

2027-12-30

Last updated by the study team

2025-12-12

Who can join

Age: 25 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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)
• impaired insulin sensitivity (glucose 100-125 mg/dL and/or insulin >15 (uM/ml), and may be diagnosed with T2D (blood glucose >126 mg/dL).

You may not qualify if…

• pregnancy, lactation

Where it is running

• Human Nutrition Research Unit - Li Ka Shing Health Research Center — Edmonton, Alberta, Canada (enrolling)
• Mazankowski Alberta Heart Institute — Edmonton, Alberta, Canada (enrolling)
• University of Alberta Hospital - Division of Endocrinology — Edmonton, Alberta, Canada (enrolling)

Full record on ClinicalTrials.gov

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