EUCTR2008-000815-13-DE进行中（未招募）不适用
Analysis of cerebral, renal, peripheral, and retinal hemodynamics in adults with type 2 diabetes before, during, and after administration of pioglitazone or placebo.
Technical University Munich0 个研究点开始时间: 2008年4月3日最近更新:
适应症
相关药物
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
- •Written informed consent
- •Age 18 - 95 years
- •Fasting blood sugar (FBS) > 200 mg/dl and / or HbA1c > 5,9% or antidiabetic treatment
- •Adequate bilateral temporal bone windows for sufficient TCD examination and symmetrical perfusion of the middle cerebral artery (MCA)
- •Cardio- / cerebrovascular disease
- •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
- •General Exclusion Criteria
- •Participation in another pharmacologic study in the last 30 days
- •Known or possible pregnancy or breastfeeding
- •Cognitive impairment or other reasons interfering with patient compliance
- •Known malignancy in the last 5 years
- •Specific Exclusion Criteria
- •Hemodynamically relevant stenoocclusive disease of the extracranial and / or intracranial cerebral arteries diagnosed by doppler sonography
- •TIA or stroke in the last 3 months
- •Carotid endarteriectomy or angioplasty in the last 3 months
- •Insulin dependency
- •Diabetic ketoacidosis
- •Body mass index (BMI) > 35 kg/m2
- •Premedication with thiazolidindiones
- •Start of treatment with statins in the last 3 months
- •Start of treatment with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers in the last 3 months
- •Known drug intolerance against thiazolidindiones
- •Known drug intolerance against indicator substances (PAH, IN)
- •Known drug intolerance against tropicamide
- •Known liver disease (GOT and / or GPT > 2.5 x upper normal limit)
- •Known renal insufficiency (serum creatinine > 1.2 mg/dl and / or creatinine clearance < 30 ml/min according to the Cockroft formula)
- •Known microalbuminuria
- •Known anaemia (haemoglobin < 11 g/dl (male), < 10 g/dl (female))
- •Known heart insufficiency (NYHA I-IV)
- •Advanced pulmonary disease
- •Known angle-closure glaucoma
研究者
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