Risk Analysis for Diabetic Cardiovascular Autonomic Neuropathy

Completed

• Conditions: Diabetic Cardiovascular Autonomic Neuropathy
• Interventions: Other: not intervention

• Registration Number: NCT02461472
• Lead Sponsor: Shanghai Tongji Hospital, Tongji University School of Medicine

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.

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: 2019-02
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-19
• Last Update Posted: 2019-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2000

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:

  1. history or findings of arrhythmia and hyperthyroidism or hypothyroidism
  2. pregnancy or lactation
  3. serious hepatic or renal dysfunctions (GFR < 30 mL/min/1.73m2).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dr.Tang's research group	not intervention	Dr.Tang's research group for clinical risk analysis of human complex disease

Primary Outcome Measures

Name	Time	Method
Cardiovascular Autonomic Neuropathy (CAN) measured by short-term short-term heart rate variability (HRV)	participants will be measured for the duration of outpatient stay, an expected average of 2 weeks

Trial Locations

Locations (1)

Huasha Hospital; 🇨🇳 Shanghai, Shanghai, China