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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

June 1, 2009
May 25, 2012
June 2009
May 2010   (final data collection date for primary outcome 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. [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00919347 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
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The Relative Prevalence and Severity of Autonomic Nervous System Dysfunction
The Relative Prevalence and Severity of Autonomic Nervous System Dysfunction in Diabetic Patients Undergoing Retinal Surgery

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Not Provided
Non-Probability Sample

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

  • Cardiovascular Autonomic Neuropathy
  • Diabetic Autonomic Neuropathy
  • Autonomic Dysfunction
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:

  1. RFa an indicator of parasympathetic function with normal values between 0.5 and 10 bpm2;
  2. LFa an indicator of sympathetic function also with normal values between 0.5 and 10 bpm2;
  3. 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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
May 2010
May 2010   (final data collection date for primary outcome measure)

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
Both
19 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00919347
F080909006
Yes
Gwendolyn L. Boyd, MD, University of Alabama at Birmingham
University of Alabama at Birmingham
Not Provided
Not Provided
University of Alabama at Birmingham
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP