Fish oil plus metformin for heart health in women with PCOS
Dietary Fish Oil and Metformin Intervention for Heart Health in PCOS
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 |
| Enrollment | 146 (estimated) |
| Ages | 25 Years to 45 Years |
| Sex | Female |
| Sponsor | University of Alberta Academic / other |
| Locations | 3 sites (Edmonton, Alberta and 2 other locations) |
| Trial ID | NCT06424860 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Edmonton, Alberta and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.