NCT00533065已完成不适用
Effects of the Cholinesterase Inhibitor Donepezil on Organic and Functional Deficits Associated With Age-Related Decrease of Growth Hormone
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Serum IGF1
研究概览
简要总结
The planned study has two purposes:
- It is to provide evidence that the administration of a cholinesterase inhibitor will result in an increase of IGF-I (primary variable) and in an increase of the secretion growth hormone (secondary variable) that can be maintained throughout the treatment-period of one year.
- The study also tests the hypothesis that maintenance of increased blood levels of growth hormone and IGF-I can stop or delay the age-related changes of body composition (secondary variables) .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 70 and 80 years
排除标准
- •Cardiac arrhythmias (sick sinus syndrome, AV block, sino-atrial block),
- •Treatment with beta-blockers, NSAIDs or cholinergic agonists,
- •Known hypersensitivity to donepezil hydrochloride, piperidine derivatives or to any excipients used in the formulation,
- •Gastric and duodenal ulcer,
- •Severe renal and hepatic impairment,
- •Urinary congestion (prostatic hypertrophy),
- •Obstructive pulmonary disease (bronchial asthma);
结局指标
主要结局
Serum IGF1
时间窗: one year
次要结局
- Growth hormone, body composition variables(one year)
研究者
研究点 (2)
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