EUCTR2004-002579-17-DE进行中（未招募）不适用
A double-blind, randomised placebo controlled study of the effects of Acarbose on endothelial function, hemostatic and fibrinolytic plasmatic factors in patients with stable coronary artery disease and either impaired glucose intolerance or newly diagnosed diabetes mellitus
Medizinische Klinik B, Herzzentrum Ludwigshafen0 个研究点开始时间: 2006年6月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male and female subjects aged between 40 and 75 years with IGT/new diagnosed diabetes, with body mass index between 25 and 40 kg/m2
- •2. Patients with stable angina pectoris (<=CCS II) and angiographically documented coronary artery disease not requiring immediate revascularization
- •3. Informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Current smokers
- •- Participation in an other clinical study during the previous 1,5 months
- •- Evidence of significant hepatic, renal, cardiac or pulmonary insufficiency
- •- History of malignant neoplasms (treated within the last 1 year) other than basal cell
- •carcinoma of the skin.
- •- Other serious diseases, which might influence the clinical course
- •- Recent major surgery or childbirth
- •- Pregnancy or lactation
- •- History of malabsorption
- •- regular intake of narcotics
- •- regular intake of more than 30 g alcohol for female or 40 g alcohol for male
- •- a clear deviation from the norm at the clinical findings, which, in the opinion of the Investigator, would preclude unequivocal interpretation of the findings.
- •- Contraindication to Acarbose or previous interrupted Acarbose treatment due to serious side effects.
- •- Type I diabetes
- •-Pre-treatment with alpha-glucosidase inhibitors, metformin or other drugs, influencing insulin resistance.
- •- Pre-treatment of ACE-inhibitors and statins because of their influence on endothelial function.
- •- poor metabolic control (HBA1c>8), plasma glucose level up to 300 mg/dL postprandial
研究者
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