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Recruiting NCT06424860

Fish Oil, Metformin and Heart Health in PCOS

Phase I Interventional PCOS Cardiovascular Disease Atherosclerotic Cardiovascular Disease Atherosclerotic Plaque

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fish oil, Metformin, Fish Oil and Metformin.
Who it may be relevant to
Registry conditions: PCOS, Cardiovascular Disease, Atherosclerotic Cardiovascular Disease, Atherosclerotic Plaque. Basic parameters: 25 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Dietary Fish Oil and Metformin Intervention for Heart Health in PCOS

Overview

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.

Interventions

  • Dietary supplement Fish oil
    For 12 months
  • Drug Metformin
    12 months
  • Combination product Fish Oil and Metformin
    12 months

Primary outcome measures

  • Carotid intimal medial thickness [Time frame: 12 months]
  • carotid plaque height [Time frame: 12 months]
  • Left ventricular global longitudinal strain (LVGLS) [Time frame: 12 months]
Secondary outcome measures (6)
  • Blood lipids [Time frame: 12 months]
  • ApoB-lipoproteins [Time frame: 12 months]
  • remnant-cholesterol [Time frame: 12 months]
  • Testosterone [Time frame: 12 months]
  • insulin [Time frame: 12 months]
  • glucose [Time frame: 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Canada · 3 centers
  • Human Nutrition Research Unit - Li Ka Shing Health Research Center — Edmonton
  • Mazankowski Alberta Heart Institute — Edmonton
  • University of Alberta Hospital - Division of Endocrinology — Edmonton

Identifiers

NCT: NCT06424860 · 00141704

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗