The Relative Prevalence and Severity of Autonomic Nervous System Dysfunction in Diabetic Patients Undergoing Retinal Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiovascular Autonomic Neuropathy
- Sponsor
- University of Alabama at Birmingham
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
Gwendolyn L. Boyd, MD
Principal Investigator
University of Alabama at Birmingham
Eligibility 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
Outcomes
Primary Outcomes
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.
Time Frame: 15 minutes
Secondary Outcomes
- 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)