Fish Oil, Metformin and Heart Health in PCOS

Dietary Fish Oil and Metformin Intervention for Heart Health in PCOS

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiovascular Disease; PCOS; Cardiac Hypertrophy; Atherosclerotic Cardiovascular Disease; Atherosclerotic Plaque
• Intervention / Treatment: Drug: Metformin; Dietary supplement: Fish oil; Combination product: Fish Oil and Metformin

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 Type: Interventional
• Enrollment (Estimated): 146
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Metformin; metformin (1500mg/d) and placebo (olive oil capsule)	Drug: Metformin; 12 months
Experimental: Fishoil and metformin; metformin (1500mg/d) and fish oil (4000mg/d)	Dietary supplement: Fish oil; For 12 months; Combination product: Fish Oil and Metformin; 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Carotid intimal medial thickness	mm	12 months
carotid plaque height	mm	12 months
Left ventricular global longitudinal strain (LVGLS)	percent change in LVGLS	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Alberta
• Collaborators: Heart and Stroke Foundation of Canada

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: April 29, 2024
• First Submitted That Met QC Criteria: May 16, 2024
• First Posted (Actual): May 22, 2024

Study Record Updates

• Last Update Posted (Estimated): June 18, 2024
• Last Update Submitted That Met QC Criteria: June 17, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Cardiovascular Diseases; Hypertrophy; Atherosclerosis; Cardiomegaly; Plaque, Atherosclerotic; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: 00141704

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: no plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No