{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T20:27:55Z","timestamp":1792787275447,"version":"4.5.0"},"reference-count":128,"publisher":"BMJ","issue":"9","license":[{"start":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T00:00:00Z","timestamp":1789689600000},"content-version":"unspecified","delay-in-days":17,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004411","name":"Heart and Stroke Foundation of Canada","doi-asserted-by":"publisher","award":["G-23-0033990"],"award-info":[{"award-number":["G-23-0033990"]}],"id":[{"id":"10.13039\/100004411","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Alberta Women's Health Foundation\/Women and Children\u2019s Health Research Institute at the University of Alberta","award":["NA"],"award-info":[{"award-number":["NA"]}],"id":[{"id":"https:\/\/ror.org\/0160cpw27","id-type":"ROR","asserted-by":"crossref"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2026,7,30]]},"published-print":{"date-parts":[[2026,9]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Polyendocrine metabolic ovarian syndrome (PMOS) (formerly known as polycystic ovary syndrome) is a metabolic-endocrine disorder that affects 8\u201313% 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>\n                      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 &gt;25\u2009kg\/m\n                      <jats:sup>2<\/jats:sup>\n                      ), are aged 25\u201345 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\u2009g\/day) or the control group receiving a placebo over a 12-month period; participants in both groups will receive standard-of-care metformin (1500\u2009mg\/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.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT06424860\">NCT06424860<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  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