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

January 5, 2021 updated by: Zihui Tang, Shanghai Tongji Hospital, Tongji University School of Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200065
        • Shanghai Tongji Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
This is a cross-sectional study for estimation of diagnostic performance.
Other Names:
  • nothing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diabetic cardiovascular autonomic function evaluate by short-term heart rate variability test
Time Frame: participants will be measured for the duration of outpatient stay, an expected average of two days
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
Time Frame: participants will be measured for the duration of outpatient stay, an expected average of two days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Tongji Hospital, Tongji University School of Medicine

Investigators

  • Principal Investigator: Zihui Tang, M.D and Ph.D, Shanghai Tongji Hospital, Tongji University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2020

Study Registration Dates

First Submitted

June 1, 2015

First Submitted That Met QC Criteria

June 2, 2015

First Posted (Estimate)

June 3, 2015

Study Record Updates

Last Update Posted (Actual)

January 6, 2021

Last Update Submitted That Met QC Criteria

January 5, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCANHRVB_Dr.Tang

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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