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
  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: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Relative Prevalence and Severity of Autonomic Nervous System Dysfunction in Diabetic Patients Undergoing Retinal Surgery

Resource links provided by NLM:


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
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Gwendolyn L. Boyd, MD, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00919347     History of Changes
Other Study ID Numbers: F080909006
Study First Received: June 1, 2009
Last Updated: May 25, 2012
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:
Nervous System Diseases
Diabetic Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 28, 2014