NCT00919347

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 19 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiovascular Autonomic Neuropathy
• Diabetic Autonomic Neuropathy
• Autonomic Dysfunction

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-06-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2009-06-12
• Last updated: 2012-05-28

Locations

1 site across 1 country: United States