NCT00628056Unknown1 期
Mechanisms Responsible for Cardiac and Skeletal Muscle Energetic Impairment in Diabetes
University Hospital Birmingham1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2006年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- The primary end point of the Perhexiline intervention study will be the change in cardiac PCr/ATP ratio.
研究概览
简要总结
Diabetes increases the risk of heart failure. This is mainly due to a disease of the blood vessels supplying the heart muscle and/or high blood pressure, but abnormal metabolism may also contribute. We plan to study the mechanisms involved in this abnormal metabolism, whilst also assessing the effects of a drug called Perhexiline which improves the abnormal metabolism that is present in diabetic patients before the development of heart failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes Mellitus(WHO definition)
- •HbA1C <9
- •No history of chest pain
- •No evidence of Coronary Artery Disease or peripheral vascular disease
- •Left ventricular ejection fraction over 50%
- •No evidence of respiratory disease
排除标准
- •Patients < 16years or who cannot provide informed consent
- •Evidence of significant epicardial coronary artery disease
- •Evidence of peripheral vascular disease
- •Abnormal liver function tests
- •Clinically apparent peripheral neuropathy
- •Severe chronic renal failure (creatinine >250) or diabetic nephropathy
- •Concomitant use of Amiodarone, Quinidine, Haloperidol or Selective serotonin (5HT) uptake inhibitors such as Fluoxetine and Paroxetine which may inhibit the CYP2D6 enzyme
- •Patients on statin therapy for primary dyslipidemia.
- •Patients with recurrent hypoglycaemia
- •Women of child bearing age who are not using effective contraception (or if pregnancy test positive)
研究组 & 干预措施
1
Active Comparator
干预措施: Perhexiline (Drug)
2
Placebo Comparator
干预措施: Perhexiline (Drug)
结局指标
主要结局
The primary end point of the Perhexiline intervention study will be the change in cardiac PCr/ATP ratio.
时间窗: 2 Weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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