Work

Effect of fish oil as an adjunct therapy to metformin on vascular and cardiac health in women with polyendocrine metabolic ovarian syndrome: protocol for a randomised, placebo-controlled clinical trial

Year: 2026

Type: article

Abstract: 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: ), 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. TRIAL REGISTRATION NUMBER: NCT06424860.

Source: BMJ Open

DOI: 10.1136/bmjopen-2026-124025