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Clinical Trials/NCT02461342
NCT02461342
Completed
Not Applicable

Genetic, Environment and Its Interaction Analysis for Cardiovascular Autonomic Neuropathy in Chinese Population

Shanghai Tongji Hospital, Tongji University School of Medicine2 sites in 1 country2,100 target enrollmentJanuary 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiovascular Autonomic Neuropathy
Sponsor
Shanghai Tongji Hospital, Tongji University School of Medicine
Enrollment
2100
Locations
2
Primary Endpoint
cardiovascular autonomic neuropathy (CAN) measured by short-term heart rate variability (HRV)
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

A large-scale, community-based, cross-sectional study was conducted to explore the extent to which genetic, environment and its interactions associated with cardiovascular autonomic neuropathy (CAN) in general Chinese population. A total of more than 2000 participants were recruited by using multiple stages sampling (first cluster sampling and then simply sampling). Data involved in variables of genetic, environment were collected. Every participants was complete DNA extracted and genotyped by using single nucleotide polymorphism (SNP). Cardiovascular autonomic functions were measured by using short-term heart rate variability (HRV) to evaluate the outcome of CAN. Genetic analysis were employed to evaluate genetic variants, environmental risk factors and its interactions for CAN.

Detailed Description

A large-scale, community-based, cross-sectional study was conducted to explore the extent to which genetic, environment and its interactions associated with cardiovascular autonomic neuropathy (CAN) in general Chinese population. A total of more than 2000 participants were recruited by using multiple stages sampling (first cluster sampling and then simply sampling). Data involved in variables of genetic, environment were collected. Every participant was complete DNA extracted and genotyped by using single nucleotide polymorphism (SNP). Cardiovascular autonomic functions were measured by using short-term heart rate variability (HRV) to evaluate the outcome of CAN. Genetic analysis were employed to evaluate genetic variants, environmental risk factors and its interactions for CAN.Univariate and multiple variables analysis have been performed to examine potential environmental and genetic risk factors of CAN.

Registry
clinicaltrials.gov
Start Date
January 2011
End Date
July 2016
Last Updated
9 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 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:
  • history or findings of arrhythmia and hyperthyroidism or hypothyroidism
  • pregnancy or lactation
  • serious hepatic or renal dysfunctions (GFR \< 30 mL/min/1.73m2). Of these subjects, complete baseline data were obtained for 2,092 (69.46%) of the participants.

Outcomes

Primary Outcomes

cardiovascular autonomic neuropathy (CAN) measured by 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 (2)

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