Effects of Fish Oil Supplementation on Vascular Structure and Function in Hypertensive Patients With Hypertriglyceridemia
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Endothelial function
研究概览
简要总结
The objective of this study is to compare the effects of ciprofibrate versus omega-3 fatty acid supplementation on the vascular structure and function in hypertensive patients with hypertriglyceridemia.
详细描述
Hypertensive patients aged 40-65 years, both genders, presenting serum triglycerides levels higher than 150 mg/dl will be randomized into two groups. The first group will be receiving ciprofibrate 100mg/day and the second group will be receiving fish oil 1800mg/day. All patients will be evaluated with brachial flow-mediated dilation and with EndoPAT to assess endothelial function before and after supplementation. SPHYGMOCOR and pulse wave velocity (PWV) measurements will also be obtained.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previous diagnosis of hypertension
- •Patients with serum triglycerides levels ≥ 150 mg/dl and <500 mg/dl
- •Patients on stable antihypertensive medication for at least 4 weeks
- •Patients with food consumption maintained for at least 4 weeks
排除标准
- •Secondary hypertension
- •Hormone replacement therapy
- •Diabetes mellitus
- •Chronic kidney disease
- •Known coronary artery disease
- •Previous stroke
- •Dyslipidemia severe, with LDL cholesterol> 160 mg/dL or triglycerides ≥ 500 mg/dl
- •Use of statins or beta blockers
研究组 & 干预措施
Ciprofibrate
干预措施: Ciprofibrate (Drug)
Omega-3 fatty acid
干预措施: DHA-EPA (Dietary Supplement)
结局指标
主要结局
Endothelial function
时间窗: 3 months
Endothelial function evaluated by brachial flow-mediated dilation and by peripheral arterial tonometry.
次要结局
未报告次要终点
研究者
Mario Fritsch Neves
MD, PhD
Hospital Universitario Pedro Ernesto