Recruiting
Phase 1

Fish Oil with Metformin

Sponsor:

University of Alberta

Code:

NCT06424860

Conditions

PCOS

Cardiovascular Disease

Atherosclerotic Cardiovascular Disease

Atherosclerotic Plaque

Cardiac Hypertrophy

Eligibility Criteria

Sex: Female

Age: 25 - 45

Healthy Volunteers: Not accepted

Interventions

Fish oil

Metformin

Fish Oil and Metformin

Study Details

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.

Conditions

PCOS

Cardiovascular Disease

Atherosclerotic Cardiovascular Disease

Atherosclerotic Plaque

Cardiac Hypertrophy

Study ID

NCT06424860

Start date

Nov 1, 2025

Status verified date

Dec, 2025

Completion date

Dec 30, 2027

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 25 - 45

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

146 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Metformin

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

experimental: Fishoil and metformin

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

Interventions

Fish oil

For 12 months

Metformin

12 months

Fish Oil and Metformin

12 months

Primary outcome measure

  • Carotid intimal medial thickness [ Time Frame: 12 months ]
  • carotid plaque height [ Time Frame: 12 months ]
  • Left ventricular global longitudinal strain (LVGLS) [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Donna Vine, PhD

780-492-4393dvine@ualberta.ca

Locations

Human Nutrition Research Unit - Li Ka Shing Health Research Center

Recruiting

Edmonton, Alberta, Canada, T6G 2E1

Contacts

Donna Vine, PhD

780-492-4393dvine@ualberta.ca

Beate Sydora, PhD

780-940-1476bsydora@ualberta.ca

Mazankowski Alberta Heart Institute

Recruiting

Edmonton, Alberta, Canada, T6G-2B7

Contacts

Donna Vine, PhD

780-492-4393dvine@ualberta.ca

Beate Sydora, PhD

780-940-1476bsydora@ualberta.ca

University of Alberta Hospital - Division of Endocrinology

Recruiting

Edmonton, Alberta, Canada, T6G-2B7

Contacts

Beate Sydora, PhD

7804920302reoffice@ualberta.ca

More Information

Sponsor

University of Alberta

Last update posted

Dec 12, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-27. This information was provided to ClinicalTrials.gov by University of Alberta on 2025-12-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.