Fish Oil, Metformin and Heart Health in PCOS

Официальное название

Dietary Fish Oil and Metformin Intervention for Heart Health in PCOS

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка Fish oil
  For 12 months
• Препарат Metformin
  12 months
• Комбинированный продукт Fish Oil and Metformin
  12 months

Первичные конечные точки

• Carotid intimal medial thickness [Срок оценки: 12 months]
• carotid plaque height [Срок оценки: 12 months]
• Left ventricular global longitudinal strain (LVGLS) [Срок оценки: 12 months]

Вторичные конечные точки (6)

• Blood lipids [Срок оценки: 12 months]
• ApoB-lipoproteins [Срок оценки: 12 months]
• remnant-cholesterol [Срок оценки: 12 months]
• Testosterone [Срок оценки: 12 months]
• insulin [Срок оценки: 12 months]
• glucose [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 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).

Критерии исключения

-pregnancy, lactation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Канада · 3 центра

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

Идентификаторы

NCT: NCT06424860 · 00141704

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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