Regulation of Inflammatory Parameters by Telmisartan in Hypertensive Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- change in IL-6
研究概览
简要总结
A number of studies have shown that certain blood-pressure medications such as ACE-inhibitors and angiotensin-II-receptor blockers (ARB) can reduce the incidence of diabetes mellitus type 2. This protocol will evaluate whether inflammatory mechanisms mediate this effect. The investigators therefore will investigate the effect of telmisartan, a potent ARB, on lipid metabolism, glucose metabolism and inflammation in patients with the metabolic syndrome. Specific parameters will be tested before treatment and after 3 months of treatment. Placebo will be compared to 2 different doses of telmisartan per day.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Abd. obesity (BMI>25kg/m²) and waist circumference ≥95cm (men),≥80cm (women)
- •Blood pressure ≥130 mmHg (systolic) and/or ≥85 mmHg (diastolic)
- •Triglycerides 150-400 mg/dl
- •Normal stress test
- •Normal carotid ultrasound
- •Normal fundoscopy
排除标准
- •Diabetes mellitus
- •Secondary cause for insulin resistance
- •LDL-cholesterol >190 mg/dl
- •Atherosclerotic disease
- •Blood pressure >160 mmHg (systolic) and/or >100 mmHg (diastolic)
- •Regular alcohol consumption (>30 g/day)
- •Contraindication against telmisartan
- •Antihypertensive medications
- •Lipid lowering therapy
- •Malignancy
- •Pregnancy or Lactation
- •Women without adequate contraception
研究组 & 干预措施
T1
Telmisartan 80 mg/d
干预措施: telmisartan (Drug)
T2
Telmisartan 160 mg/d
干预措施: telmisartan (Drug)
P
placebo
干预措施: placebo (Drug)
结局指标
主要结局
change in IL-6
时间窗: 14 weeks
次要结局
- change in fasting lipids;(14 weeks)
- change in postprandial lipid metabolism(14 weeks)
- change in inflammatory parameters(14 weeks)
- change in glucose metabolism(14 weeks)