Pyridostigmine and Its Effects on Autonomic Modulation in Diabetic Patients With Autonomic Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- autonomic modulation assessed by heart rate variability
研究概览
简要总结
The purpose of the study is to determine if pyridostigmine bromide improves heart rate variability of type 2 diabetes mellitus subjects with cardiovascular autonomic neuropathy.
详细描述
The reduced heart rate variability is associated with increased risk of death in patients with diabetes mellitus. Cholinesterase inhibition with pyridostigmine bromide increases heart rate variability in normal individuals and congestive heart failure subjects but its effects on patients with diabetes mellitus is unknown. Based on those evidences, we will test if the short-term administration of pyridostigmine bromide increases heart rate variability in patients with diabetes mellitus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diabetes mellitus
排除标准
- •myocardial infarction
- •acute ischemic syndromes
- •second or third degree atrioventricular block
- •active alcoholism
- •thyroid dysfunction
- •chronic obstructive pulmonary disease
- •history of intolerance to pyridostigmine.
研究组 & 干预措施
Pyridostigmine
干预措施: Pyridostigmine (Drug)
Placebo
If a subject is randomized to placebo, he will receive placebo pills 3 times daily for 1 day.
干预措施: Placebo (Drug)
结局指标
主要结局
autonomic modulation assessed by heart rate variability
时间窗: 1 day
次要结局
未报告次要终点