The Effect of 6-month Treatment With Coenzyme Q10 on Endothelial, Vascular and Myocardial Function in Patients With Non-alcoholic Fatty Liver Disease
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The effect of Q10 on Left Ventricular Myocardial Function
研究概览
简要总结
Non-alcoholic fatty liver disease (NAFLD) is associated with increased cardiovascular risk. The aim of this study is to investigate the effects of coenzyme Q10 (CoQ10) on endothelial, vascular and myocardial function in patients with NAFLD
详细描述
Non-alcoholic fatty liver disease (NAFLD) is associated with increased cardiovascular risk. The aim of this study is to investigate the effects of coenzyme Q10 (CoQ10) on endothelial, vascular and myocardial function in patients with NAFLD. In this trial patients with NAFLD will receive 240mg Q10 or placebo. At baseline and at 6 months, will be measured: a) Perfused boundary region (PBR) of the sublingual vessels using the SideviewDarkfieldimaging technique (Microscan, Glycocheck), b) pulse wave velocity (PWV-Complior, ALAM), c) flow-mediated dilation (FMD) of the brachial artery, d) left ventricular (LV) global longitudinal strain (GLS), and e) controlled attenuation parameter (CAP)for the quantification of liver steatosis by liver elastography (Fibroscan, Echosens).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NAFLD AND one of below :
- •dyslipidemia, as it is defined in the metabolic syndrome
- •increased waist circumference as defined in the metabolic syndrome
- •Arterial hypertension,
- •overweight, (BMI>25)
- •polycystic ovary syndrome,
排除标准
- •Chronic Kidney Disease
- •Heart Failure
- •Liver failure
- •Pregnancy/ Breast feeding
- •Active malignancy (receiving Chemotherapy/immunotherapy)
研究组 & 干预措施
Q10
干预措施: Q10 (Drug)
Placebo
干预措施: Q10 (Drug)
结局指标
主要结局
The effect of Q10 on Left Ventricular Myocardial Function
时间窗: Six months
The effect of Q10 on Left Ventricular Global Longitudinal Strain after six month administration of Q10
次要结局
未报告次要终点
研究者
VAIA LAMBADIARI
Professor of Internal Medicine-Endocrinology
Attikon Hospital