Fish Oil, Metformin and Heart Health in PCOS

University of Alberta

Status and phase: Not yet enrolling; Phase 1

Conditions: PCOS; Atherosclerotic Cardiovascular Disease; Cardiac Hypertrophy; Atherosclerotic Plaque; Cardiovascular Disease

Treatments: Dietary Supplement: Fish oil; Drug: Metformin; Combination Product: Fish Oil and Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT06424860

00141704

Details and patient eligibility

About

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.

Full 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.

Enrollment: 146 estimated patients

Sex: Female

Ages: 25 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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146 participants in 2 patient groups

Metformin

Active Comparator group

Description:

metformin (1500mg/d) and placebo (olive oil capsule)

Treatment:

Drug: Metformin

Fishoil and metformin

Experimental group

Description:

metformin (1500mg/d) and fish oil (4000mg/d)

Treatment:

Combination Product: Fish Oil and Metformin

Dietary Supplement: Fish oil