The Relative Prevalence and Severity of Autonomic Nervous System Dysfunction

Autonomic Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00919347
• Other study ID #: F080909006
• Status: Completed
• Phase: N/A
• First received: June 1, 2009
• Last updated: May 25, 2012
• Start date: June 2009
• Est. completion date: May 2010

Study information

• Verified date: May 2012
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 70 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Autonomic Dysfunction
• Autonomic Nervous System Diseases
• Cardiovascular Autonomic Neuropathy
• Diabetic Autonomic Neuropathy
• Diabetic Neuropathies
• Nervous System Diseases
• Primary Dysautonomias

Intervention

Other:
• ANSAR ANX 3.0 Software
Three values are calculated by the ANSAR ANX 3.0® software of the spectral analysis of HRV and respiration: RFa an indicator of parasympathetic function with normal values between 0.5 and 10 bpm2; LFa an indicator of sympathetic function also with normal values between 0.5 and 10 bpm2; SB or the ratio of LFa/RFa with normal reference values of 0.4 to 3.0. The ANSAR ANX 3.0® software defines three different levels of autonomic neuropathy (autonomic dysfunction) as follows (see Figure 1): Cardiovascular Autonomic Neuropathy (CAN): resting parasympathetic insufficiency (not enough parasympathetic protection for the heart) or RFa < 0.1 bpm2. Diabetic Autonomic Neuropathy (DAN), or advanced autonomic dysfunction in non-diabetics, is defined as low autonomics: LFa < 0.5 bpm2 or 0.1 < RFa < 0.5 bpm2. Autonomic Dysfunction: normal resting LFa and RFa, but low LFa response to Valsalva or low RFa response to deep breathing.

Locations

Country	Name	City	State
United States	Callahan Eye Foundation Hospital	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No