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

T

Tongji University

Status

Completed

Conditions

Diabetic Cardiovascular Autonomic Neuropathy (DCAN)

Treatments

Other: not intervention

Study type

Observational

Funder types

Other

Identifiers

NCT02461381
DCANHRVB_Dr.Tang

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

30 to 90 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

200 participants in 1 patient group

Dr.Tang's research group
Description:
This group included diabetic participants with completed both the short-term HRV test and Ewing's test.
Treatment:
Other: not intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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