ISRCTN42786336已完成不适用
Pancreatic beta-cell dysfunction REStorEd by Rosiglitazone and Valsartan Effects: a 52-week randomised controlled factorial study in subjects with impaired fasting glucose and/or impaired glucose tolerance
VU University Medical Center (The Netherlands)0 个研究点目标入组 144 人开始时间: 2006年9月28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
- 144
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
- All
入选标准
- •1. Male and female subjects (aged 35 to 70 years)
- •2. Impaired Fasting Glucose (IFG): fasting plasma glucose 6.1 or higher and less than 7.0 mmol/l, or fasting plasma glucose 5.6 or higher and less than 7.0 mmol/l) and a family history of Diabetes Mellitus type two (DM2) (i.e. first and second degree [i.e. grandparents] relatives)
- •3. Impaired Glucose Tolerance (IGT): two hour plasma glucose during 75 g oral glucose tolerance test 7.8-11.1 mmol/l
排除标准
- •1. Current use of Angiotensin-Converting Enzyme Inhibitors (ACE-I), Angiotensin Receptor Blockers (ARB) and/or Thiazolidinediones (TZDs) and inability to discontinue these drugs
- •2. Known hypersensitivity to any of the study drugs
- •3. Prior use of blood glucose lowering medications except during pregnancy
- •4. Use of systemic glucocorticoids or niacin
- •Cardiovascular co-morbidities:
- •1. Ejection fraction known to be less than 40% or congestive heart failure, or existing clinical Cardio-Vascular (CV) disease:
- •a. previous Myocardial Infarction [MI] or stroke
- •b. angina with either more than 50% stenosis in more than or equal to two major coronary arteries, or ST depression of more than or equal to 2 mm, or a positive nuclear test, or previous coronary angioplasty, stent or bypass
- •c. previous limb bypass or vessel angioplasty or angiographic evidence of more than 50% stenosis, or intermittent claudication with an ankle/arm pressure less than or equal to 0.8
- •2. Uncontrolled hypertension requiring ACE-I or ARB
- •Other Criteria:
- •1. History of diabetes (except gestational DM) or on anti-diabetic medication
- •2. Renal or Hepatic Disease:
- •a. renal artery stenosis
- •b. creatinine clearance less than 40 ml/min or serum creatinine 200 umol/l or higher
- •c. clinical proteinuria (one or above, positive proteinuria on dipstick or 300 mg and above albuminuria/day, in the absence of urine)
- •d. measured Alanine Transferase (ALT) 2.5 or more times the upper limit of normal
- •e. active liver disease including jaundice, chronic hepatitis, previous liver transplant
- •3. Major illness with life expectancy of less than five years or that may interfere with participation
- •4. Use of another experimental drug
- •5. Pregnant or unwilling to use reliable contraception (fertile women will have a pregnancy test prior to randomisation)
- •6. Major psychiatric disorder
- •7. Diseases and medications that affect glucose tolerance (e.g. pheochromocytoma, Cushing?s syndrome, acromegaly, steroid-dependent asthma, protease inhibitors, anti-psychotics)
- •8. Unwillingness to be randomised or sign informed consent)
- •9. Known uncontrolled substance abuse
- •10. Inability to understand study information and/or communicate with clinic staff
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