The Relative Prevalence and Severity of Autonomic Nervous System Dysfunction
Completed
Conditions studied: Cardiovascular Autonomic Neuropathy, Diabetic Autonomic Neuropathy, Autonomic Dysfunction
In brief
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.
Key facts
- Study ID
- NCT00919347
- Run by
- University of Alabama at Birmingham
- People needed
- 100
- Starts
- 2009-06-01
- Expected to finish
- 2010-05-01
- Last updated by the study team
- 2012-05-28
Who can join
Age: 19 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Callahan Eye Foundation Hospital — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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