ACTRN12609000053224已完成2 期
Pilot study of the effects on cardiac diastolic function of GC811007, a fructosamine oxidase inhibitor, in patients with Type 2 diabetes and diabetic cardiomyopathy
Protemix Corporation0 个研究点目标入组 30 人开始时间: 2009年1月23日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 30 Years 至 70 Years（—）
- 性别
- All
入选标准
- •Age between 30 and 70 years; known type 2 diabetes; HbA1c > 7.0% at enrollment; normal electrocardiogram; abnormal diastolic filling as demonstrated by mitral inflow Doppler with pre-load reduction LV ejection fraction = 45% by echocardiography, with evidence of diastolic dysfunction but no regional wall-motion abnormalities; no new medications for six months prior to randomization with no change of ß-blocker dose during that period.
排除标准
- •Morbid obesity (BMI = 45 kg.m-2); type 1 diabetes; history or evidence of diabetic retinopathy and/or diabetic nephropathy (serum creatinine > 150 µmol/l and/or urinary albumin > 300 mg/l); autonomic neuropathy; significant cardiac valvular disease; LV wall motion abnormality by echocardiography; history of significant malabsorption; multiple drug allergies; use or misuse of substances of abuse; evidence of abnormal electrolyte homeostasis or renal, hepatic or thyroid function; or standard contraindications to MRI
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