The Relative Prevalence and Severity of Autonomic Nervous System Dysfunction
Information source: University of Alabama at Birmingham
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cardiovascular Autonomic Neuropathy; Diabetic Autonomic Neuropathy; Autonomic Dysfunction
Intervention: ANSAR ANX 3.0 Software (Other)
Phase: N/A
Status: Not yet recruiting
Sponsored by: University of Alabama at Birmingham Overall contact:
Debbie M Owen, BS, Phone: 205-975-2088, Email: debbieo@uab.edu
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.
Clinical Details
Official title: The Relative Prevalence and Severity of Autonomic Nervous System Dysfunction in Diabetic Patients Undergoing Retinal Surgery
Study design: Case Control, Prospective
Primary outcome: 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.
Secondary outcome: 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
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.
Eligibility
Minimum age: 19 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
Debbie M Owen, BS, Phone: 205-975-2088, Email: debbieo@uab.edu
Callahan Eye Foundation Hospital, Birmingham, Alabama 35233, United States
Additional Information
Starting date: June 2009
Ending date: June 2009
Last updated: June 11, 2009
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