The Relative Prevalence and Severity of Autonomic Nervous System Dysfunction - Full Text View

Sponsor:	University of Alabama at Birmingham
Information provided by:	University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT00919347

Purpose

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	Intervention
Cardiovascular Autonomic Neuropathy Diabetic Autonomic Neuropathy Autonomic Dysfunction	Other: ANSAR ANX 3.0 Software

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	The Relative Prevalence and Severity of Autonomic Nervous System Dysfunction in Diabetic Patients Undergoing Retinal Surgery

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Surgery

Drug Information available for: Hydroxyzine Hydroxyzine pamoate Hydroxyzine dihydrochloride

U.S. FDA Resources

Further study details as provided by University of Alabama at Birmingham:

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. [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]

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 [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	June 2009
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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.

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

Ages Eligible for Study:	19 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

The study population will consist of patiented from the Callahan Eye Foundation.

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00919347

Locations

United States, Alabama
Callahan Eye Foundation Hospital
Birmingham, Alabama, United States, 35233

Sponsors and Collaborators

University of Alabama at Birmingham

More Information

No publications provided

Responsible Party:	University of Alabama at Birmingham ( Gwendolyn Boyd, MD )
Study ID Numbers:	F080909006
Study First Received:	June 1, 2009
Last Updated:	November 19, 2009
ClinicalTrials.gov Identifier:	NCT00919347 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:

Cardiovascular Autonomic Neuropathy
Diabetic Autonomic Neuropathy
Autonomic Dysfunction

Additional relevant MeSH terms:

Neuromuscular Diseases
Diabetic Neuropathies
Peripheral Nervous System Diseases
Nervous System Diseases

Diabetes Mellitus
Endocrine System Diseases
Diabetes Complications

ClinicalTrials.gov processed this record on February 08, 2010