The Relative Prevalence and Severity of Autonomic Nervous System Dysfunction

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Gwendolyn L. Boyd, MD, University of Alabama at Birmingham

ClinicalTrials.gov Identifier:

NCT00919347

First received: June 1, 2009

Last updated: May 25, 2012

Last verified: May 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	June 1, 2009
Last Updated Date	May 25, 2012
Start Date ^ICMJE	June 2009
Primary Completion Date	May 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 11, 2009)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00919347 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 11, 2009)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The Relative Prevalence and Severity of Autonomic Nervous System Dysfunction
Official Title ^ICMJE	The Relative Prevalence and Severity of Autonomic Nervous System Dysfunction in Diabetic Patients Undergoing Retinal Surgery
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.
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case Control Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	The study population will consist of patiented from the Callahan Eye Foundation.
Condition ^ICMJE	Cardiovascular Autonomic Neuropathy Diabetic Autonomic Neuropathy Autonomic Dysfunction
Intervention ^ICMJE	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.
Study Group/Cohort (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	100
Completion Date	May 2010
Primary Completion Date	May 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	19 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00919347
Other Study ID Numbers ^ICMJE	F080909006
Has Data Monitoring Committee	Yes
Responsible Party	Gwendolyn L. Boyd, MD, University of Alabama at Birmingham
Study Sponsor ^ICMJE	University of Alabama at Birmingham
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Alabama at Birmingham
Verification Date	May 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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