An observational study in Cardiovascular Autonomic Neuropathy, Diabetic Autonomic Neuropathy and Autonomic Dysfunction, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 19 Years to 70 Years. Per ClinicalTrials.gov, last updated 2012-05-28.
Sponsored by University of Alabama at Birmingham · Observational
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.
1,003 studies on the registry are indexed under Peripheral Nervous System Diseases; 177 are open to participants now.
This study's planned enrollment of 100 is above the median of 90 across 188 observational studies indexed under Peripheral Nervous System Diseases.
Browse Peripheral Nervous System Diseases studies →University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.
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The study population will consist of patiented from the Callahan Eye Foundation.
Exclusion Criteria:
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.
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
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
This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.
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Peripheral Nervous System Diseases→
University of Alabama at Birmingham