Fish Oil, Metformin and Heart Health in PCOS

NCT06424860 · tracked via the Priya Life Science Canada tracker

Sponsor

University of Alberta

Phase

Phase 1

Started

2025-11-01

Last updated

2025-12-12

Condition(s) studied

PCOSCardiovascular DiseaseAtherosclerotic Cardiovascular DiseaseAtherosclerotic PlaqueCardiac Hypertrophy

Investigational drug(s) / intervention(s)

Fish oilMetformin →Fish Oil and Metformin

Fish oil: For 12 months

Metformin: 12 months

Fish Oil and Metformin: 12 months

Study summary

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

Sex

FEMALE

Min age

25 Years

Max age

45 Years

Healthy volunteers

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

Primary outcome measure(s)

Carotid intimal medial thickness — 12 months
mm
carotid plaque height — 12 months
mm
Left ventricular global longitudinal strain (LVGLS) — 12 months
percent change in LVGLS

Trial sites (3)

Facility	City	Region	Status
Human Nutrition Research Unit - Li Ka Shing Health Research Center	Edmonton	Alberta	Recruiting
Mazankowski Alberta Heart Institute	Edmonton	Alberta	Recruiting
University of Alberta Hospital - Division of Endocrinology	Edmonton	Alberta	Recruiting

On this site

📄 Glucophage (metformin) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06424860 on ClinicalTrials.gov ↗ ← All trials in Canada