The Relative Prevalence and Severity of… | Clinical Trial

Key information

Conditions

Cardiovascular Autonomic Neuropathy Autonomic Dysfunction Autonomic Nervous System Diseases Diabetes Complications Diabetes Mellitus Diabetic Autonomic Neuropathy Diabetic Neuropathies Endocrine System Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Primary Dysautonomias

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Callahan Eye Foundation Hospital

Birmingham, Alabama, 35233, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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:

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.

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

The Relative Prevalence and Severity of Autonomic Nervous System Dysfunction in Diabetic Patients Undergoing Retinal Surgery

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Jun 12, 2009
Registry last updated: May 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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