Fish Oil, Metformin and Heart Health in PCOS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-01

Study Completion Date

2027-12-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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PCOS Cardiovascular Disease Atherosclerotic Cardiovascular Disease Atherosclerotic Plaque Cardiac Hypertrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Metformin

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

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

12 months

Fishoil and metformin

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

Group Type EXPERIMENTAL

Fish oil

Intervention Type DIETARY_SUPPLEMENT

For 12 months

Fish Oil and Metformin

Intervention Type COMBINATION_PRODUCT

12 months

Interventions

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Fish oil

For 12 months

Intervention Type DIETARY_SUPPLEMENT

Metformin

12 months

Intervention Type DRUG

Fish Oil and Metformin

12 months

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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).