Status:
COMPLETED
The Relative Prevalence and Severity of Autonomic Nervous System Dysfunction
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Cardiovascular Autonomic Neuropathy
Diabetic Autonomic Neuropathy
Eligibility:
All Genders
19-70 years
Brief Summary
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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2010
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00919347
Start Date
June 1 2009
End Date
May 1 2010
Last Update
May 28 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Callahan Eye Foundation Hospital
Birmingham, Alabama, United States, 35233