Fish oil plus metformin for heart health in women with PCOS
Official title: Dietary Fish Oil and Metformin Intervention for Heart Health in PCOS
Run by University of Alberta · NCT06424860 · Data updated 2026-11-12
This trial will test whether taking dietary fish oil with metformin improves heart-related measures, blood fats, and insulin–glucose control in overweight women with PCOS, including some with type 2 diabetes.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 25 Years to 45 Years |
| Sex | Women only |
| Enrollment | 146 (estimated) |
| Sponsor | University of Alberta Academic / other |
| Locations | 3 sites (Edmonton, Alberta and 2 other locations) |
| Status | Recruiting |
| Started | November 1, 2025 |
| Main results expected | December 30, 2026 |
| Study ends | December 30, 2027 |
| Registry record updated | December 12, 2025 |
| Trial ID | NCT06424860 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women with a clinical diagnosis of PCOS who are overweight or obese (BMI >25 kg/m2) with elevated fasting triglycerides (>150 mg/dL) and/or elevated apoB48 remnant lipoproteins (>20 µg/mL) and evidence of impaired insulin sensitivity or type 2 diabetes.
✕Probably not a fit
Women who are not overweight, have normal triglycerides and remnant lipoproteins, have normal insulin–glucose measures, or who are pregnant or breastfeeding are unlikely to benefit or are ineligible for this trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 1 interventional study compares dietary fish oil supplementation combined with standard-of-care metformin versus metformin alone for 12 months in overweight or obese women with PCOS who have elevated triglycerides or remnant lipoproteins and impaired insulin sensitivity. Primary outcomes include changes in fasting and non-fasting plasma triglycerides, apoB48 and apoB100 remnant lipoproteins, carotid intima-media thickness and plaque height, and cardiac function measures such as left ventricular posterior wall thickness and ejection fraction. Participants will undergo baseline and follow-up blood testing, vascular imaging, and cardiac assessments at University of Alberta sites in Edmonton. The study aims to generate evidence on whether fish oil can be a safe nutritional adjunct to metformin to reduce early cardiovascular risk in young women with PCOS.
Why it matters
Potential benefit: If successful, adding fish oil to metformin could reduce early cardiovascular risk by improving blood lipids and insulin–glucose control in young women with PCOS.
How similar studies have gone: Prior studies show omega-3 fish oil reliably lowers triglycerides but evidence for reducing atherosclerosis or improving cardiac structure in PCOS, especially as an adjunct to metformin, is limited, making this combination relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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). Exclusion Criteria: -pregnancy, lactation
Where it's running
-
Human Nutrition Research Unit - Li Ka Shing Health Research Center
Edmonton, Alberta, Canada Recruiting -
Mazankowski Alberta Heart Institute
Edmonton, Alberta, Canada Recruiting -
University of Alberta Hospital - Division of Endocrinology
Edmonton, Alberta, Canada Recruiting
Study contacts
- Study coordinator: Donna Vine, PhD
- Email: dvine@ualberta.ca
- Phone: 780-492-4393
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.