Risk Analysis for Diabetic Cardiovascular Autonomic Neuropathy

March 19, 2019 updated by: Zihui Tang, Shanghai Tongji Hospital, Tongji University School of Medicine

The Risk Analysis for Diabetic Cardiovascular Autonomic Neuropathy in General 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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

2000

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, 200040
        • Huasha 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

The investigators recruited participants from rural and urban communities in Shanghai. Survey diabetic participants with undiagnosed DCAN, aged 30-90 years, were included in this study. Our study invited a total of 3000 subjects to a screening visit between 2013 and 2015.

Description

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 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
Dr.Tang's research group for clinical risk analysis of human complex disease
Other: not intervention
This is a cross-sectional study, no intervention was performed.
Other Names:
  • nothing

What is the study measuring?

Primary Outcome Measures

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

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

Collaborators

Huashan Hospital

Investigators

  • Principal Investigator: Zihui Tang, M.D and Ph.D, Huashan Hospital

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)

February 1, 2019

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)

March 20, 2019

Last Update Submitted That Met QC Criteria

March 19, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCANRA_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.

Clinical Trials on Diabetic Cardiovascular Autonomic Neuropathy

Clinical Trials on not intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe