The Relative Prevalence and Severity of Autonomic Nervous System Dysfunction

NCT00919347 | Completed DMC

• 1 other identifier: F080909006
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Autonomic Neuropathy; Diabetic Autonomic Neuropathy; Autonomic Dysfunction

Keywords

Cardiovascular Autonomic Neuropathy; Diabetic Autonomic Neuropathy; Autonomic Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Interventions

ANSAR ANX 3.0 Software OTHER

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.

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

Callahan Eye Foundation Hospital

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Diabetic Neuropathies; Primary Dysautonomias

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Autonomic Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 1, 2009
• First Posted: June 12, 2009
• Study Start: June 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: May 28, 2012

Record last verified: 2012-05

Locations

US (1)