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The Relative Prevalence and Severity of Autonomic Nervous System Dysfunction - NCT00919347-35233(Clinical Trial 297631)



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City:  Birmingham
State:  
AL
Zip Code: 35233
Conditions: Cardiovascular Autonomic Neuropathy - Diabetic Autonomic Neuropathy - Autonomic Dysfunction
Purpose: 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.
Study 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 (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.
Criteria: Inclusion Criteria: - 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 Criteria: - 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
Study is available at: Callahan Eye Foundation Hospital
Birmingham, AL 35233
United States

Primary Contact:
Jeff Worrell, BSN
Email: jworrell@uab.edu
Phone: 205-975-2098

Secondary Contact:
Jeff Worrell, BSN
Email: jworrell@uab.edu
Phone: 205-975-2098
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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