NCT00657865已完成4 期
Gene Expression Profiling in Skeletal Muscle of Healthy Subjects Treated With Ramipril
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Genome-wide gene expression measurements in skeletal muscle at baseline and in response to ramipril intake.
研究概览
简要总结
This project investigates the effect of ACE-inhibition on cellular metabolism by gene expression profiling of human muscle tissue, obtained by biopsy prior to and after ramipril intake.
This should contribute to our understanding of the pathomechanisms involved in diabetes and the clinical effect of ACE-inhibition on patients with diabetes/metabolic syndrome.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy defined as absence of relevant disease
- •Caucasian
- •Aged 18-45 years
- •BMI: 18-28 kg/m2
- •Signed informed consent
- •Blood pressure between 110/45 and <140/90 (twice at screening)
排除标准
- •History of renal artery stenosis
- •angioneurotic edema
- •psoriasis
- •relevant renal diseases
- •RR at screening < 110/45 mmHg.
- •Diabetes, history of hypertension, RR > 140/90 at screening, cardiovascular disease
- •Known Diabetes mellitus of parents
- •HIV or Hepatitis B/C positive virology
- •Allergy or hypersensitivity against ACE-inhibitors / ramipril or to xylocain
- •Contraindications against the use of the drug according to the SmPC, history of angioedema
- •Any drug intake 3 weeks prior to first study day
- •History of excessive bleeding tendency / hemophilia
- •Presence of relevant illness within the last 3 weeks
- •Suspected non-compliance with study instructions and life-style requirements
- •Alcohol or drug abuse
- •Blood/Plasma donation within 4 weeks prior to study day
- •Previous exposure to antihypertensive drugs, ACE-inhibitors, in particular ramipril
- •Current smoking (any quantity), (at least 6 months of non-smoking required)
研究组 & 干预措施
1
Active Comparator
Ramipril
干预措施: ramipril (Drug)
2
Placebo Comparator
Placebo
干预措施: placebo (Drug)
结局指标
主要结局
Genome-wide gene expression measurements in skeletal muscle at baseline and in response to ramipril intake.
时间窗: 1 year
次要结局
未报告次要终点
研究者
Markus Mueller
Prof. Dr
Medical University of Vienna
研究点 (1)
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