Dietary Fish Oil and Metformin Intervention for Heart Health in PCOS
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 146
- 试验地点
- 3
- 主要终点
- carotid plaque height
研究概览
简要总结
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.
详细描述
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;
- 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.
- 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.
- To assess the effect of dietary fish oil supplementation on insulin, glucose, and endocrine parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •pregnancy, lactation
研究组 & 干预措施
Metformin
metformin (1500mg/d) and placebo (olive oil capsule)
干预措施: Metformin (Drug)
Fishoil and metformin
metformin (1500mg/d) and fish oil (4000mg/d)
干预措施: Fish oil (Dietary Supplement)
Fishoil and metformin
metformin (1500mg/d) and fish oil (4000mg/d)
干预措施: Fish Oil and Metformin (Combination Product)
结局指标
主要结局
carotid plaque height
时间窗: 12 months
mm
Carotid intimal medial thickness
时间窗: 12 months
mm
Left ventricular global longitudinal strain (LVGLS)
时间窗: 12 months
percent change in LVGLS
次要结局
- Testosterone(12 months)
- insulin(12 months)
- glucose(12 months)
- Blood lipids(12 months)
- ApoB-lipoproteins(12 months)
- remnant-cholesterol(12 months)