Bayesian Estimation of Diagnostic Performance of Diabetic Cardiovascular Autonomic Neuropathy Without a Gold Standard

NCT02461381 | Completed DMC

• 1 other identifier: DCANHRVB_Dr.Tang
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Diabetic cardiovascular autonomic function evaluate by short-term heart rate variability test

  Both short-term heart rate variability and Ewing's test measure diabetic cardiovascular autonomic function

  participants will be measured for the duration of outpatient stay, an expected average of two days

• Diabetic cardiovascular autonomic function evaluate by Ewing's test

  Both short-term heart rate variability and Ewing's test measure cardiovascular autonomic function

  participants will be measured for the duration of outpatient stay, an expected average of two days

Study Arms (1)

Dr.Tang's research group

This group included diabetic participants with completed both the short-term HRV test and Ewing's test.

Other: not intervention

Interventions

not intervention OTHER

This is a cross-sectional study for estimation of diagnostic performance.

Also known as: nothing

Dr.Tang's research group

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Tongji Hospital, Tongji University School of Medicine: lead

Study Sites (1)

Shanghai Tongji Hospital

Shanghai, Shanghai Municipality, 200065, China

Location

Related Publications (6)

• 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.

  PMID: 23770583 RESULT

• 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.

  PMID: 24360155 RESULT

• 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.

  PMID: 24633734 RESULT

• 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.

  PMID: 25287103 RESULT

• 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.

  PMID: 23940593 RESULT

• 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.

  PMID: 26366204 DERIVED

Study Officials

• Zihui Tang, M.D and Ph.D

  Shanghai Tongji Hospital, Tongji University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D and Ph.D

Study Record Dates

• First Submitted: June 1, 2015
• First Posted: June 3, 2015
• Study Start: January 1, 2013
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2020
• Last Updated: January 6, 2021

Record last verified: 2021-01

Locations

CN (1)