ISRCTN53177482已完成不适用
Pioglitazone Influence of triglyceRide Accumulation in the Myocardium In Diabetes
VU University Medical Centre (Netherlands)0 个研究点目标入组 90 人开始时间: 2005年12月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
入选标准
- •Type two diabetes patients:
- •1. Type two diabetes diagnosed male patients aged 45 to 65 years (diagnosed according to World Health Organisation [WHO] criteria)
- •2. Treated by monotherapy of sulfanylurea (i.e. unchanged during more than 30 days prior to inclusion)
- •3. At least three months stable HbA1c (less than 8.5%) under this therapy
- •4. Sitting blood pressure less than 150/85 mmHg with or without anti-hypertensive drugs
- •5. Body Mass Index (BMI) less than 32 kg/m^2
- •Healthy volunteers:
- •1. Healthy male subjects, 45 to 65 years
- •2. Normal sitting blood pressure less than 150/85 mmHg
- •3. BMI less than 32 kg/m^2
- •4. Normal glucose tolerance as assessed by 75 g oral glucose tolerance test
排除标准
- •Type two diabetes patients:
- •1. Coronary Artery Disease (CAD)
- •2. Active malignant disease
- •3. Impaired renal function (serum creatinine more than 176 mmol/l)
- •4. Weight greater than or equal to 45 kg (because of 11C-palmitate tracer)
- •5. Anti-coagulant therapy
- •6. Severe obstructive lung disease
- •7. Hereditary lipoprotein disease
- •8. Impaired hepatic function (defined as Alanine aminotransferase [ALT] more than three Upper Limit of Normal [ULN]) or a history of liver disease
- •9. Inability to understand study information
- •10. Inability/unwillingness to sign informed consent
- •11. Substance abuse
- •12. Familial polyposis coli
- •13. Less than three months after participation in other clinical trials or other research projects, whereby radiation is used
- •14. Haemoglobin less than 8 mmol/l
- •15. Metal implants and claustrophobia
- •16. Incompatible with Cardiovascular Magnetic Resonance (CMR)
- •17. Congestive heart failure (New York Heart Association [NYHA] functional score more than one)
- •18. Atrial fibrillation or history of sustained ventricular tachycardia
- •19. Stroke within six months prior to enrolment
- •20. Microvascular complications including:
- •a. diabetic nephropathy
- •b. proliferative retinopathy
- •c. symptomatic macrovascular complications, and/or
- •d. (autonomic) neuropathy, except for background diabetic retinopathy, leg ulcers, gangrene, hypersensibility to study medication, current use of Thiazolidinediones (TZD)/fibrates
- •Healthy volunteers:
- •1. History or current cardiovascular disease
- •2. Dyslipidemia, requiring pharmacological treatment according to the Dutch Cholesterol Consensus 1998
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