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Clinical Trials/NCT02461472
NCT02461472
Completed
Not Applicable

The Risk Analysis for Diabetic Cardiovascular Autonomic Neuropathy in General Chinese Population

Shanghai Tongji Hospital, Tongji University School of Medicine1 site in 1 country2,000 target enrollmentJanuary 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetic Cardiovascular Autonomic Neuropathy
Sponsor
Shanghai Tongji Hospital, Tongji University School of Medicine
Enrollment
2000
Locations
1
Primary Endpoint
Cardiovascular Autonomic Neuropathy (CAN) measured by short-term short-term heart rate variability (HRV)
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

A large-scale, community-based, cross-sectional study was conducted to explore the extent to which risk factors associated with diabetic cardiovascular autonomic neuropathy (DCAN) in general Chinese population. A total of more than 2000 diabetic participants were recruited by using multiple stages sampling (first cluster sampling and then simply sampling). Data involved in demographic information, clinical biomarkers such as glucose and lipids profiles, medical and therapy history were collected. Every participants was complete DNA extracted and genotyped. Diabetic Cardiovascular autonomic functions were measured by using short-term heart rate variability (HRV) to evaluate the outcome of DCAN. Univariate and multiple variables analysis have been performed to examine potential environmental and genetic risk factors of CAN. In addition, clinical risk model, simply screening model and nonlinear system model such as artificial neural network was created, respectively.

Detailed Description

Little is known about the risk factors and risk models for diabetic cardiovascular autonomic neuropathy in Chinese population. A large-scale, community-based, cross-sectional study was conducted to explore the extent to which risk factors associated with diabetic cardiovascular autonomic neuropathy (DCAN) in general Chinese population. A total of more than 2000 diabetic participants were recruited by using multiple stages sampling (first cluster sampling and then simply sampling). Data involved in demographic information, clinical biomarkers such as glucose and lipids profiles, medical and therapy history were collected. Every participants was complete DNA extracted and genotyped. Diabetic Cardiovascular autonomic functions were measured by using short-term heart rate variability (HRV) to evaluate the outcome of DCAN. Univariate and multiple variables analysis have been performed to examine potential environmental and genetic risk factors of CAN. In addition, clinical risk model, simply screening model and nonlinear system model such as artificial neural network was created, respectively.

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
February 2019
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Shanghai Tongji Hospital, Tongji University School of Medicine
Responsible Party
Principal Investigator
Principal Investigator

Zihui Tang

M.D and Ph.D

Huashan Hospital

Eligibility Criteria

Inclusion Criteria

  • Survey Chinese participants with undiagnosed DCAN Aged 30-90 years, were included in this study.

Exclusion Criteria

  • Some diabetic patients were excluded from the study to eliminate potential confounding factors that may have influenced their CA function. Briefly, the exclusion criteria were as follows:
  • history or findings of arrhythmia and hyperthyroidism or hypothyroidism
  • pregnancy or lactation
  • serious hepatic or renal dysfunctions (GFR \< 30 mL/min/1.73m2).

Outcomes

Primary Outcomes

Cardiovascular Autonomic Neuropathy (CAN) measured by short-term short-term heart rate variability (HRV)

Time Frame: participants will be measured for the duration of outpatient stay, an expected average of 2 weeks

Study Sites (1)

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