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

Diabetic Cardiovascular Autonomic Neuropathy (DCAN) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02461381
• Other study ID #: DCANHRVB_Dr.Tang
• Status: Completed
• Start date: January 2013
• Est. completion date: August 2020

Study information

• Verified date: January 2021
• Source: Shanghai Tongji Hospital, Tongji University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 2020
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Cardiovascular Autonomic Neuropathy (DCAN)
• Nervous System Diseases
• Peripheral Nervous System Diseases

Intervention

Other:
• not intervention
This is a cross-sectional study for estimation of diagnostic performance.

Locations

Country	Name	City	State
China	Shanghai Tongji Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Tongji Hospital, Tongji University School of Medicine

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View 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. Prin — View 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-20 — View 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 — View 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. E — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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