Actively Recruiting
Dietary Fish Oil and Metformin Intervention for Heart Health in PCOS
Led by University of Alberta · Updated on 2025-12-12
146
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University of Alberta
Lead Sponsor
H
Heart and Stroke Foundation of Canada
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the effects of dietary fish oil supplementation combined with metformin compared to metformin alone on heart health, blood lipids, and insulin-glucose metabolism in overweight or obese women with Polycystic Ovary Syndrome (PCOS), including those with Type 2 Diabetes. The study focuses on young women at high risk for cardiovascular disease due to their condition and aims to provide evidence for fish oil as a safe addition to current treatments. Participants will be randomly assigned to receive either metformin (1500 mg daily) with a placebo or metformin (1500 mg daily) combined with fish oil supplementation (4000 mg daily) for 12 months. The study will measure effects on plasma lipids and lipoproteins, atherosclerotic cardiovascular disease markers, and cardiac function, including carotid intimal medial thickness, plaque height, and left ventricular global longitudinal strain. During the 12-month study, participants will undergo assessments such as blood tests for lipids, insulin, glucose, and testosterone, as well as imaging to measure carotid artery thickness and heart function. Researchers will monitor changes in these parameters to understand how fish oil alongside metformin may influence cardiovascular risk and metabolic factors in women with PCOS. Safety and adherence will be tracked throughout the study period.
CONDITIONS
Brief Title
Fish Oil, Metformin and Heart Health in PCOS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Polycystic Ovary Syndrome (PCOS)
- Overweight or obese with a body mass index (BMI) over 25 kg/m2
- Elevated fasting plasma triglycerides over 150 mg/dL
- Elevated apoB48-remnant cholesterol lipoproteins over 20 ug/ml
- Impaired insulin sensitivity (glucose 100-125 mg/dL and/or insulin over 15 uM/ml)
- May have Type 2 Diabetes with blood glucose over 126 mg/dL
- Female aged between 25 and 45 years
You will not qualify if you...
- Pregnancy or lactation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants receive metformin with or without fish oil supplementation daily for 12 months to assess effects on cardiovascular and metabolic health.
Regular visits during the 12-month treatment period
Trial Site Locations
Total: 3 locations
1
Human Nutrition Research Unit - Li Ka Shing Health Research Center
Edmonton, Alberta, Canada, T6G 2E1
Actively Recruiting
2
Mazankowski Alberta Heart Institute
Edmonton, Alberta, Canada, T6G-2B7
Actively Recruiting
3
University of Alberta Hospital - Division of Endocrinology
Edmonton, Alberta, Canada, T6G-2B7
Actively Recruiting
Research Team
D
Donna Vine, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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