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

Completed

• Conditions: Diabetic Cardiovascular Autonomic Neuropathy (DCAN)
• Interventions: Other: not intervention

• Registration Number: NCT02461381
• Lead Sponsor: Shanghai Tongji Hospital, Tongji University School of Medicine

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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2015-06-01
• Study First Submitted QC: 2015-06-02
• Study First Posted: 2015-06-03
• Primary Completion: 2018-08
• Study Completion: 2020-08
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-05
• Last Update Posted: 2021-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Diabetic cardiovascular autonomic function evaluate by short-term heart rate variability test	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
Diabetic cardiovascular autonomic function evaluate by Ewing's test	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

Trial Locations

Locations (1)

Shanghai Tongji Hospital; 🇨🇳 Shanghai, Shanghai, China