The Effects of 90-day Monotherapies With Atorvastatin, Fenofibrate and Combined Therapy With Atorvastatin and Fenofibrate on Lipid Profile, Fasting Plasma Glucose, Proinflammatory Cytokines and Adipokines
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Adipokines
研究概览
简要总结
The study is planned to show whether monotherapies or combined hypolipemic therapy influence the fasting plasma glucose, serum adipokines (leptin, adiponectin, resistin) and proinflammatory cytokines (interleukin-6, TNF alpha) during 30 and 90 day course.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 35 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age (35-64yr)
- •Primary hyperlipidemia (Total cholesterol >200mg/dl, Triglycerides >150mg/dl)
- •Impaired fasting glycemia (glycemia 100-125mg/dl)
- •For women:
- •Menopause (>12 months)
- •Post hysterectomy
- •Mechanical contraception
- •Obtained informed consent
排除标准
- •Secondary hyperlipidemia
- •Morbid obesity (BMI>40kg/m2)
- •Alcohol or drug abuse
- •Acute or chronic inflammation
- •Congestive Heart Failure (NYHA III or IV)
- •Unstable Ischaemic Heart Disease
- •Moderate or severe hypertension
- •Cancer in less than 5 years
- •Chronic kidney disease (stage III-V)
- •Liver failure
- •Oral contraception
- •Not compliant patient
- •Laboratory results:
- •alanine transferase (>3xULN)
- •creatine kinase (>5xULN)
- •haemoglobin (<10/dl)
- •PLT (<100G/l)
- •WBC (<3,5G/l or >10G/l)
研究组 & 干预措施
Atorvastatin
10mg of Atorvastatin
干预措施: To compare monotherapies and combined therapy with each other (Drug)
Fenofibrate
267mg of Fenofibrate
干预措施: To compare monotherapies and combined therapy with each other (Drug)
Fenofibrate and atorvastatin
10mg of Atorvastatin and 267mg of fenofibrate
干预措施: To compare monotherapies and combined therapy with each other (Drug)
Therapeutic Lifestyle Change
Placebo and Therapeutic Lifestyle Change
干预措施: To compare monotherapies and combined therapy with each other (Drug)
结局指标
主要结局
Adipokines
时间窗: Day 90
Serum concentration of leptin, adiponectin and resistin on Day 90 of the treatment.
次要结局
- Proinflammatory cytokines(Day 90)
- Adipokines(Day 30)