The Relative Prevalence and Severity of Autonomic Nervous System Dysfunction

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Completed

CT.gov ID

NCT00919347

Collaborator

(none)

100

Enrollment

Location

Duration (Months)

9.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Autonomic Neuropathy Diabetic Autonomic Neuropathy Autonomic Dysfunction	Other: ANSAR ANX 3.0 Software

Detailed Description

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

The Relative Prevalence and Severity of Autonomic Nervous System Dysfunction in Diabetic Patients Undergoing Retinal Surgery

Study Start Date :

Jun 1, 2009

Actual Primary Completion Date :

May 1, 2010

Actual Study Completion Date :

May 1, 2010

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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