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

NCT ID: NCT02461381

Last Updated: 2021-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2020-08-31

Brief Summary

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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

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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.

Conditions

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Diabetic Cardiovascular Autonomic Neuropathy (DCAN)

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Dr.Tang's research group

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

not intervention

Intervention Type OTHER

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

Interventions

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not intervention

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

Intervention Type OTHER

Other Intervention Names

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nothing

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

30 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shanghai Tongji Hospital, Tongji University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Zihui Tang

M.D and Ph.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zihui Tang, M.D and Ph.D

Role: PRINCIPAL_INVESTIGATOR

Shanghai Tongji Hospital, Tongji University School of Medicine

Locations

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Shanghai Tongji Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type RESULT
PMID: 23770583 (View on PubMed)

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.

Reference Type RESULT
PMID: 24360155 (View on PubMed)

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.

Reference Type RESULT
PMID: 24633734 (View on PubMed)

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.

Reference Type RESULT
PMID: 25287103 (View on PubMed)

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.

Reference Type RESULT
PMID: 23940593 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26366204 (View on PubMed)

Other Identifiers

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DCANHRVB_Dr.Tang

Identifier Type: -

Identifier Source: org_study_id

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