Fish Oil, Metformin and Heart Health in PCOS

Phase 1

Not yet recruiting

• Conditions: Atherosclerotic Plaque; PCOS; Cardiovascular Disease; Cardiac Hypertrophy; Atherosclerotic Cardiovascular Disease
• Interventions: Drug: Metformin; Dietary Supplement: Fish oil; Combination Product: Fish Oil and Metformin

• Registration Number: NCT06424860
• Lead Sponsor: University of Alberta

Brief Summary

Women with Polycystic Ovary Syndrome (PCOS) have high testosterone levels which is associated with altered insulin-glucose metabolism and an adverse blood lipid profile, predisposing them to the development of Type II Diabetes and Cardiovascular Disease (CVD). This study will investigate the use of dietary fish oil supplementation as a safe and effective intervention, and as an adjunct therapy to standard of care treatment with metformin to improve heart health, blood lipids and insulin-glucose metabolism in women with PCOS, and those with PCOS and Type 2 Diabetes.

Detailed Description

OBJECTIVES The objective in this proposed study is to determine the effect of dietary fish oil supplementation with metformin compared to standard of care metformin-alone treatment for 12 months on plasma lipids and apoB- remnant lipoprotein metabolism, and atherosclerotic cardiovascular disease and cardiac function in high-risk overweight-obese young individuals with PCOS.

This study will provide evidence-based research on the efficacy of fish oil, in the form as an adjunct therapy to standard treatment with metformin, as a safe nutritional treatment to add to therapeutic guidelines to reduce early CVD risk in young women with PCOS.

Specific Objectives;

1. To quantify carotid intimal medical thickness (cIMT) and plaque height before and after the intervention to assess the effect of fish oil supplementation combined with metformin standard of care on atherosclerotic cardiovascular disease and cardiac function.

2. To determine the effects of dietary fish oil supplementation combined with metformin and metformin standard of care on fasting and non-fasting plasma TG, apoB48 and apoB100-lipoprotein concentrations, and cardiac function variables including left ventricular (LV) posterior wall thickness, LV ejection fraction.

3. To assess the effect of dietary fish oil supplementation on insulin, glucose, and endocrine parameters.

Study Timeline

• Study First Submitted: 2024-04-29
• Study First Submitted QC: 2024-05-16
• Study First Posted: 2024-05-22
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-22
• Study Start: 2025-06-15
• Primary Completion: 2026-06-30
• Study Completion: 2027-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 146

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin	Metformin	metformin (1500mg/d) and placebo (olive oil capsule)
Fishoil and metformin	Fish Oil and Metformin	metformin (1500mg/d) and fish oil (4000mg/d)
Fishoil and metformin	Fish oil	metformin (1500mg/d) and fish oil (4000mg/d)

Primary Outcome Measures

Name	Time	Method
carotid plaque height	12 months	mm
Carotid intimal medial thickness	12 months	mm
Left ventricular global longitudinal strain (LVGLS)	12 months	percent change in LVGLS

Secondary Outcome Measures

Name	Time	Method
Testosterone	12 months	nmol/l
insulin	12 months	pmol/l
glucose	12 months	mmol/l
Blood lipids	12 months	TG, LDL-C, HDL-C, non-HDL-C mmol/l
ApoB-lipoproteins	12 months	apob48 and apoB100 mg/l
remnant-cholesterol	12 months	mmol/l