Clinical trial NCT02461381: Bayesian Estimation of Diagnostic Performance of Diabetic Cardiovascular Autonomic Neuropathy Without a Gold Standard
Official title: Bayesian Estimation of Diagnostic Performance of Short-term Heart Rate Variability for Diabetic Cardiovascular Autonomic Neuropathy in the Absence of a Gold Standard
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Cardiovascular Autonomic Neuropathy (DCAN)
Keywords: Bayesian estimation, short-term heart rate variability, diabetic cardiovascular autonomic neuropathy, diagnostic performance
Diagnostic performance
short-term heart rate variability
diabetic cardiovascular autonomic neuropathy
DCAN
Lead sponsor: Shanghai Tongji Hospital, Tongji University School of Medicine
Sponsor class: OTHER
First posted: 2015-06-03
Enrollment: 200
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Diabetic patients with inclusion and exclusion criteria were recruited from healthy examination centres to assess cardiovascular autonomic function using both the short-term heart rate variability and Ewing's tests.

Brief summary: This study aimed to estimate sensitivities and specificities of diabetic cardiovascular autonomic neuropathy (DCAN) diagnostic tests using the Bayesian approach without a gold standard in another independence dataset.The reference the values for the short-term HRV were calculated in the investigators' previous study (including 371 healthy subjects). This study dataset contained 200 diabetic patients who completed both the short-term HRV test and Ewing's test. Simultaneous inferences about the population prevalence and the performance of each diagnostic test were possible using the Bayesian approach without a gold standard.

Detailed description: The CAN prevalence is rapidly growing in all populations worldwide. No document has been reported diagnostic performance of short-term heart rate variability (HRV) for diabetic cardiovascular autonomic neuropathy (DCAN) in the Chinese population. This study aimed to estimate sensitivities and specificities of DCAN diagnostic tests using the Bayesian approach, in the absence of a gold standard in another independence dataset.The reference the values for the short-term HRV were calculated in the investigators' previous study (including 371 healthy subjects). This study dataset contained 200 subjects who completed both the short-term HRV test and Ewing's test. Simultaneous inferences about the population prevalence and the performance of each diagnostic test were possible using the Bayesian approach without a gold standard.

Eligibility criteria: Inclusion Criteria:

* Survey diabetic participants with undiagnosed CAN, aged 30-90 years, were included in this study.

Exclusion Criteria:

* Some subjects were excluded from the study to eliminate potential confounding factors that may have influenced their CA function. Briefly, the exclusion criteria were as follows:

  1. history or findings of arrhythmia, and hyperthyroidism or hypothyroidism;
  2. pregnancy or lactation; and/or
  3. serious hepatic or renal dysfunctions.

Primary outcomes:
measure: Diabetic cardiovascular autonomic function evaluate by short-term heart rate variability test
timeFrame: participants will be measured for the duration of outpatient stay, an expected average of two days
measure: Diabetic cardiovascular autonomic function evaluate by Ewing's test
timeFrame: participants will be measured for the duration of outpatient stay, an expected average of two days
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tongji Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Tongji Hospital, Tongji University School of Medicine
name: Zihui Tang, M.D and Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li Z, Tang ZH, Zeng F, Zhou L. Associations between the severity of metabolic syndrome and cardiovascular autonomic function in a Chinese population. J Endocrinol Invest. 2013 Dec;36(11):993-9. doi: 10.3275/9005. Epub 2013 Jun 17.
citation: Tang ZH, Zeng F, Yu X, Zhou L. Bayesian estimation of cardiovascular autonomic neuropathy diagnostic test based on baroreflex sensitivity in the absence of a gold standard. Int J Cardiol. 2014 Feb 15;171(3):e78-80. doi: 10.1016/j.ijcard.2013.11.100. Epub 2013 Dec 6. No abstract available.
citation: Zeng F, Tang ZH, Li Z, Yu X, Zhou L. Normative reference of short-term heart rate variability and estimation of cardiovascular autonomic neuropathy prevalence in Chinese people. J Endocrinol Invest. 2014 Apr;37(4):385-91. doi: 10.1007/s40618-013-0047-4. Epub 2014 Jan 9.
citation: Tang ZH, Wang L, Zeng F, Li Z, Yu X, Zhang K, Zhou L. Bayesian estimation of cardiovascular autonomic neuropathy diagnostic test based on short-term heart rate variability without a gold standard. BMJ Open. 2014 Oct 6;4(9):e005096. doi: 10.1136/bmjopen-2014-005096.
citation: Tang ZH, Liu J, Zeng F, Li Z, Yu X, Zhou L. Comparison of prediction model for cardiovascular autonomic dysfunction using artificial neural network and logistic regression analysis. PLoS One. 2013 Aug 5;8(8):e70571. doi: 10.1371/journal.pone.0070571. Print 2013.
citation: Chen J, Yang SB, Liu J, Tang ZH. Diagnostic performance analysis for diabetic cardiovascular autonomic neuropathy based on short-term heart rate variability using Bayesian methods: preliminary analysis. Diabetol Metab Syndr. 2015 Sep 10;7:74. doi: 10.1186/s13098-015-0070-z. eCollection 2015.