--- title: "Fish oil plus metformin for vascular and cardiac health in women with PMOS: protocol for a randomi" id: "bmj-open-6-effect-of-fish-oil-as-an-adjunct-therapy-to-metformin-on-vascular-and-cardiac" canonical_url: "https://medichelpline.com/clinical-feed/bmj-open-6-effect-of-fish-oil-as-an-adjunct-therapy-to-metformin-on-vascular-and-cardiac" content_type: "clinical_feed_article" specialty: "Cardiology" source_name: "BMJ Open" source_url: "http://bmjopen.bmj.com/cgi/content/short/16/9/e124025?rss=1" published_at: "2026-09-18T12:04:55.000Z" evidence_level: "Journal Feed" license: "CC-BY-NC-4.0 / Informational Use" --- # Fish oil plus metformin for vascular and cardiac health in women with PMOS: protocol for a randomi ## Provenance & Clinical Metadata - **Canonical URL:** https://medichelpline.com/clinical-feed/bmj-open-6-effect-of-fish-oil-as-an-adjunct-therapy-to-metformin-on-vascular-and-cardiac - **Specialty:** [Cardiology](https://medichelpline.com/clinical-feed/cardiology.md) - **Primary Source:** BMJ Open - **Source URL:** [Original Journal Publication](http://bmjopen.bmj.com/cgi/content/short/16/9/e124025?rss=1) - **Published At:** 2026-09-18T12:04:55.000Z - **Evidence Rating:** Journal Feed ## Executive GIST (TL;DR) - This protocol describes a randomized, double-blind, placebo-controlled trial testing **fish oil** as adjunct therapy to standard-of-care **metformin** in young, high-risk women with polyendocrine metabolic ovarian syndrome (**PMOS**). - PMOS affects an estimated 8–13% of women globally and is associated with early development of cardiovascular disease driven by atherogenic dyslipidaemia, insulin resistance and elevated body weight. - The trial targets overweight or obese women (BMI >25 kg/m2) aged 25–45 years with a clinical PMOS diagnosis and elevated fasting plasma **triglyceride** or **apoB** levels. - 146 participants will be randomized 1:1 to receive either fish oil (5.96 g/day) or placebo for 12 months; all participants will receive **metformin** 1500 mg/day as standard care. - Primary vascular and cardiac endpoints are carotid intimal medial thickness (cIMT), carotid plaque height and left ventricular global longitudinal strain (LV GLS), measured by ultrasound/echocardiography and MRI where indicated. - Secondary endpoints include standard blood lipids, **apoB-lipoproteins**, hormones, and measures of glucose–insulin status, with laboratory biochemical testing to be used for these assessments. - Methodologies include MRI, ultrasound/echocardiography, standard biochemical assays, quality-of-life questionnaires and participant interviews to assess satisfaction, adherence and compliance. - Recruitment is planned from November 2025 to July 2028 at the University of Alberta Hospital and associated laboratories using self-identification, social media, flyers and clinic referrals in Edmonton and the Greater Edmonton Area. - The trial is approved by the University of Alberta Human Research Ethics Board (Pro00141704) and registered under NCT06424860; written informed consent will be obtained from all participants. - Results will be disseminated to participants, healthcare professionals and the scientific community via infographics, community presentations, scientific meetings and journal publications. ## Clinical Analysis & Structured Key Points Introduction Polyendocrine metabolic ovarian syndrome (PMOS) (formerly known as polycystic ovary syndrome) is a metabolic-endocrine disorder that affects 8 - 13% of women globally and is associated with increased cardiovascular disease (CVD) across the lifespan. CVD develops in young women due to risk factors such as atherogenic dyslipidaemia, insulin resistance and elevated body weight. High-risk overweight-obese young women with PMOS often present with subclinical CVD including atherosclerotic CVD and cardiac hypertrophy. Metformin is prescribed as standard of care to treat insulin resistance and prevent development of diabetes; however, current guidelines and treatments inadequately address atherogenic dyslipidaemia and premature subclinical CVD, particularly in young women with PMOS. The aim of this trial is to evaluate the efficacy of fish oil as an adjunct therapy to standard-of-care metformin treatment in reducing plasma triglycerides and apoB-lipoproteins, thereby preventing the progression of premature atherosclerosis and cardiac remodelling-dysfunction in young high-risk women with PMOS. Methods and analysis We will conduct a randomised, double-blind, placebo-controlled, parallel study with two intervention arms following a superiority framework. The study is being carried out at the University of Alberta Hospital and laboratories from November 2025 to July 2028. Participants will self-identify and/or be recruited from PMOS social media websites, flyers and clinics in Edmonton and the Greater Edmonton Area. Included will be women who have overweight or obesity (body mass index >25 kg/m 2 ), are aged 25 - 45 years and have a PMOS diagnosis and elevated fasting plasma triglyceride or apoB levels. The participants (n=146) will be allocated (1:1) to the experimental group receiving fish oil (5.96 g/day) or the control group receiving a placebo over a 12-month period; participants in both groups will receive standard-of-care metformin (1500 mg/day). Primary outcome measures will be carotid intimal medial thickness, carotid plaque height and left ventricular global longitudinal strain. Secondary outcomes will include blood lipids, apoB-lipoproteins, hormones and glucose-insulin. Methodologies will include standard biochemical laboratory tests, MRI and ultrasound/echocardiography. Questionnaires on quality of life and interviews exploring programme satisfaction, adherence and compliance at the beginning and end of the trial will inform future studies and PMOS management. Ethics and dissemination The study is approved by the University of Alberta Human Research Ethics Board (ethics file ID: Pro00141704). Written informed consent to participate will be obtained from all participants. Trial outcomes will be communicated to the wider public, including trial participants, healthcare professionals managing patients with PMOS and the scientific community involved in PMOS research via infographics to relevant PMOS websites, presentations in community forums and at scientific meetings, and publications in scientific journals. 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