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Can fish oil and metformin protect hearts in PCOS?

NCT ID NCT06424860

Disease control Sponsor: University of Alberta Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether taking fish oil and/or metformin for 12 months can improve heart health in women with Polycystic Ovary Syndrome (PCOS). PCOS raises the risk of heart disease and diabetes. The trial will enroll 146 women with PCOS who are overweight and have high blood fats or blood sugar. Researchers will measure changes in artery thickness, plaque, and heart function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
fish oil and metformin
What this could lead to
If it works, this could point toward a simple, low-cost way to reduce heart disease risk in women with PCOS.
What could go wrong
This is an early phase 1 trial with a small number of participants, so results may not be conclusive or apply to everyone. The interventions are generally safe, but benefits may be modest.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 146 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

25 to 45 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

atherosclerosis atherosclerotic cardiovascular disease Cardiomegaly cardiovascular disorder Plaque, Atherosclerotic polycystic ovary syndrome type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atherosclerotic cardiovascular disease Atherosclerotic plaque Cardiac hypertrophy Cardiovascular disease PCOS

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    3 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Human Nutrition Research Unit - Li Ka Shing Health Research Center

    RECRUITING

    Edmonton, Alberta, T6G 2E1, Canada

  • Mazankowski Alberta Heart Institute

    RECRUITING

    Edmonton, Alberta, T6G-2B7, Canada

  • University of Alberta Hospital - Division of Endocrinology

    RECRUITING

    Edmonton, Alberta, T6G-2B7, Canada

    Contact Email: •••••@•••••

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