Actively Recruiting

Phase 1
Age: 25Years - 45Years
FEMALE
NCT06424860

Fish Oil, Metformin and Heart Health in PCOS

Led by University of Alberta · Updated on 2025-12-12

146

Participants Needed

3

Research Sites

112 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

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.

CONDITIONS

Official Title

Fish Oil, Metformin and Heart Health in PCOS

Who Can Participate

Age: 25Years - 45Years
FEMALE

Eligibility Criteria

Eligible

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 greater than 150 mg/dL
  • Elevated apoB48-remnant cholesterol lipoproteins above 20 ug/ml
  • Impaired insulin sensitivity with fasting glucose 100-125 mg/dL and/or insulin greater than 15 uM/ml
  • May have type 2 diabetes with blood glucose over 126 mg/dL
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Lactation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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Research Team

D

Donna Vine, PhD

CONTACT

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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