Effects of High and Low Doses of Metformin, Fenofibrate and Simvastatin, Administered Together and in Sequence With Lifestyle Intervention on Lipid Profile, Glucose Metabolism, Low-grade Inflammation and Hemostasis in Patient's Blood Plasma in Type 2 Diabetic Patients With Serious Mixed Dyslipidemia
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Antiinflammatory effects of combined antidiabetic and hypolipemic treatment
研究概览
简要总结
The study is planned to show whether combined hypolipemic and antidiabetic therapy with various daily dosages influence the fasting plasma glucose, insulin sensitivity and proinflammatory cytokines in diabetic and dyslipidemic subjects.
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
- None
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)
- •Type 2 Diabetes
- •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
M1000 S10 F100
metformin 1000mg, fenofibrate 100mg and simvastatin 10mg
干预措施: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg (Drug)
M1000 S10 F267
metformin 1000mg, fenofibrate 267mg and simvastatin 10mg
干预措施: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg (Drug)
M1000 S40 F100
metformin 1000mg, fenofibrate 100mg and simvastatin 40mg
干预措施: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg (Drug)
M1000 S40 F267
metformin 1000mg, fenofibrate 267mg and simvastatin 40mg
干预措施: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg (Drug)
M2500 S10 F100
metformin 2500mg, fenofibrate 100mg and simvastatin 10mg
干预措施: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg (Drug)
M2500 S10 F267
metformin 2500mg, fenofibrate 267mg and simvastatin 10mg
干预措施: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg (Drug)
M2500 S40 F267
metformin 2500mg, fenofibrate 267mg and simvastatin 40mg
干预措施: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg (Drug)
M2500 S40 F100
metformin 2500mg, fenofibrate 100mg and simvastatin 40mg
干预措施: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg (Drug)
Therapeutic Lifestyle Change
Only therapeutic lifestyle change
干预措施: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg (Drug)
结局指标
主要结局
Antiinflammatory effects of combined antidiabetic and hypolipemic treatment
时间窗: 30 days
As inflammatory effects we measure the difference in serum concentration before and after the treatment of the following proinflammatory cytokines: 1. Interleukin 1 2. TNF alpha 3. Interleukin 6 4. Interleukin 10 5. hsCRP
次要结局
- Insulin sensitivity(30 days)
- Coagulation parameters(30 days)
研究者
Bogusław Okopień
MD PhD
Medical University of Silesia