The Relative Prevalence and Severity of Autonomic Nervous System Dysfunction in Diabetic Patients Undergoing Retinal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The primary outcome will be to quantify, using the ANSR ANX 3.0 technology, the prevalence of cardiac autonomic neuropathy (CAN), diabetic autonomic neuropathy (DAN),referred to as advanced autonomic nervous system dysfunction in non-diabetic patients.
研究概览
简要总结
The purpose of this study is to measure the prevalence and severity of cardiac autonomic neuropathy (CAN), diabetic autonomic neuropathy (DAN) which in non-diabetics is termed advanced nervous system (ANS) dysfunction, and autonomic dysfunction as well as the overall sympathovagal balance (SB) in the CEFH population of diabetic patients versus non-diabetic patients undergoing elective vitreoretinal surgery.
详细描述
The purpose of this study is to measure the prevalence and severity of cardiac autonomic neuropathy (CAN), diabetic autonomic neuropathy (DAN) which in non-diabetics is termed advanced nervous system (ANS) dysfunction, and autonomic dysfunction as well as the overall sympathovagal balance (SB) in the CEFH population of diabetic patients versus non-diabetic patients undergoing elective vitreoretinal surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type I and Type II Diabetic patients 19 or older who are scheduled for elective surgery to improve vision impaired by diabetic retinopathy
- •Patients scheduled during the same time period without diabetes for retinal surgery will serve as an age and gender matched reference group to undergo the non-invasive ANS testing on the day of surgery
排除标准
- •Inability to stand will only do baseline, deep breathing and Valsalva portions (A-D) of the testing as described in section 8.1
- •Patients with syncope on standing will only do portions A-D of the test
- •Inability to cooperate with deep breathing and Valsalva
- •Tracheoscopy or otherwise not able to perform a Valsalva
- •Not desiring to participate after informed consent
- •Known history of idiopathic dysautonomia
- •Pulmonary difficulties associated with hyperventilation, including acute URI
- •Pacemaker dependent
- •Persistently high intraocular pressure despite treatment
- •Atrial fibrillation
- •Ventricular arrhythmias greater than 10 beats per minute
- •Taking MAO inhibitors
结局指标
主要结局
The primary outcome will be to quantify, using the ANSR ANX 3.0 technology, the prevalence of cardiac autonomic neuropathy (CAN), diabetic autonomic neuropathy (DAN),referred to as advanced autonomic nervous system dysfunction in non-diabetic patients.
时间窗: 15 minutes
次要结局
- The strength of various comorbidities as predictors of autonomic dysfunction in both diabetics and non-diabetics will be evaluated. The differential effect of these various comorbidities in Type I versus Type II diabetes on ANS dysfunction and neuropathy(15 minutes)
研究者
Gwendolyn L. Boyd, MD
Principal Investigator
University of Alabama at Birmingham