Clinical trial NCT00919347: The Relative Prevalence and Severity of Autonomic Nervous System Dysfunction
Official title: The Relative Prevalence and Severity of Autonomic Nervous System Dysfunction in Diabetic Patients Undergoing Retinal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Autonomic Neuropathy
Diabetic Autonomic Neuropathy
Autonomic Dysfunction
Keywords: Cardiovascular Autonomic Neuropathy
Diabetic Autonomic Neuropathy
Autonomic Dysfunction
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2009-06-12
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of patiented from the Callahan Eye Foundation.

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.

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
* Ventricular arrhythmias greater than 10 beats per minute
* Taking MAO inhibitors

Primary outcomes:
measure: 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.
timeFrame: 15 minutes
Secondary outcomes:
measure: 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
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Callahan Eye Foundation Hospital
state: Alabama
Study officials:
References: