The Relative Prevalence and Severity of Autonomic Nervous System Dysfunction

Completed

• Conditions: Cardiovascular Autonomic Neuropathy; Diabetic Autonomic Neuropathy; Autonomic Dysfunction

• Registration Number: NCT00919347
• Lead Sponsor: University of Alabama at Birmingham

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 (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.

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 (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 Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-01
• Study First Submitted QC: 2009-06-11
• Study First Posted: 2009-06-12
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-25
• Last Update Posted: 2012-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	15 minutes

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Callahan Eye Foundation Hospital; 🇺🇸 Birmingham, Alabama, United States