NCT06424860

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P75+ for phase_1

Timeline
20mo left

Started Nov 2025

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress24%
Nov 2025Dec 2027

First Submitted

Initial submission to the registry

April 29, 2024

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 22, 2024

Completed
1.4 years until next milestone

Study Start

First participant enrolled

November 1, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

December 12, 2025

Status Verified

December 1, 2025

Enrollment Period

1.2 years

First QC Date

April 29, 2024

Last Update Submit

December 4, 2025

Conditions

Atherosclerotic Cardiovascular DiseaseAtherosclerotic PlaqueCardiac HypertrophyPCOSCardiovascular Disease

Outcome Measures

Primary Outcomes (3)

  • Carotid intimal medial thickness

    mm

    12 months

  • carotid plaque height

    mm

    12 months

  • Left ventricular global longitudinal strain (LVGLS)

    percent change in LVGLS

    12 months

Secondary Outcomes (6)

  • Blood lipids

    12 months

  • ApoB-lipoproteins

    12 months

  • remnant-cholesterol

    12 months

  • Testosterone

    12 months

  • insulin

    12 months

  • +1 more secondary outcomes

Study Arms (2)

Metformin

ACTIVE COMPARATOR

metformin (1500mg/d) and placebo (olive oil capsule)

Drug: Metformin

Fishoil and metformin

EXPERIMENTAL

metformin (1500mg/d) and fish oil (4000mg/d)

Dietary Supplement: Fish oilCombination Product: Fish Oil and Metformin

Interventions

Fish Oil and MetforminCOMBINATION_PRODUCT

12 months

Fishoil and metformin
Fish oilDIETARY_SUPPLEMENT

For 12 months

Fishoil and metformin
MetforminDRUG

12 months

Metformin

Eligibility Criteria

Age25 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • pregnancy, lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Human Nutrition Research Unit - Li Ka Shing Health Research Center

Edmonton, Alberta, T6G 2E1, Canada

RECRUITING

Mazankowski Alberta Heart Institute

Edmonton, Alberta, T6G-2B7, Canada

RECRUITING

University of Alberta Hospital - Division of Endocrinology

Edmonton, Alberta, T6G-2B7, Canada

RECRUITING

MeSH Terms

Conditions

Cardiovascular DiseasesAtherosclerosisPlaque, AtheroscleroticCardiomegaly

Interventions

Fish OilsMetformin

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsHeart DiseasesHypertrophy

Intervention Hierarchy (Ancestors)

OilsLipidsBiguanidesGuanidinesAmidinesOrganic Chemicals

Central Study Contacts

Donna Vine, PhD

CONTACT

780-492-4393dvine@ualberta.ca

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2024

First Posted

May 22, 2024

Study Start

November 1, 2025

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2027

Last Updated

December 12, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

no plan

Locations

CA(3)