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

Bayesian Estimation of Diagnostic Performance of Short-term Heart Rate Variability for Diabetic Cardiovascular Autonomic Neuropathy in the Absence of a Gold Standard

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02461381
Enrollment
200
Registered
2015-06-03
Start date
2013-01-31
Completion date
2020-08-31
Last updated
2021-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

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

Sponsors

Shanghai Tongji Hospital, Tongji University School of Medicine
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
30 Years to 90 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Diabetic cardiovascular autonomic function evaluate by short-term heart rate variability testparticipants will be measured for the duration of outpatient stay, an expected average of two daysBoth short-term heart rate variability and Ewing's test measure diabetic cardiovascular autonomic function
Diabetic cardiovascular autonomic function evaluate by Ewing's testparticipants will be measured for the duration of outpatient stay, an expected average of two daysBoth short-term heart rate variability and Ewing's test measure cardiovascular autonomic function

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026