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
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: 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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 146 participants or records.
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