NCT02461472

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

March 20, 2019

Status Verified

March 1, 2019

Enrollment Period

5.6 years

First QC Date

June 1, 2015

Last Update Submit

March 19, 2019

Conditions

Diabetic Cardiovascular Autonomic Neuropathy

Keywords

risk factorsrisk analysisdiabetic cardiovascular autonomic neuropathygeneral Chinese population

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Dr.Tang's research group

Dr.Tang's research group for clinical risk analysis of human complex disease

Other: not intervention

Interventions

not interventionOTHER

This is a cross-sectional study, no intervention was performed.

Also known as: nothing
Dr.Tang's research group

Eligibility Criteria

Age30 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huasha Hospital

Shanghai, Shanghai Municipality, 200040, China

Location

Related Publications (11)

  • Li Z, Tang ZH, Zeng F, Zhou L. Associations between the severity of metabolic syndrome and cardiovascular autonomic function in a Chinese population. J Endocrinol Invest. 2013 Dec;36(11):993-9. doi: 10.3275/9005. Epub 2013 Jun 17.

    PMID: 23770583RESULT

  • Tang ZH, Zeng F, Li Z, Zhou L. A risk score of cardiovascular autonomic dysfunction for targeted screening in the Chinese population. Int J Cardiol. 2013 Oct 12;168(5):4861-2. doi: 10.1016/j.ijcard.2013.07.062. Epub 2013 Jul 25. No abstract available.

    PMID: 23890865RESULT

  • Tang ZH, Liu J, Zeng F, Li Z, Yu X, Zhou L. Comparison of prediction model for cardiovascular autonomic dysfunction using artificial neural network and logistic regression analysis. PLoS One. 2013 Aug 5;8(8):e70571. doi: 10.1371/journal.pone.0070571. Print 2013.

    PMID: 23940593RESULT

  • Tang ZH, Zeng F, Yu X, Zhou L. Bayesian estimation of cardiovascular autonomic neuropathy diagnostic test based on baroreflex sensitivity in the absence of a gold standard. Int J Cardiol. 2014 Feb 15;171(3):e78-80. doi: 10.1016/j.ijcard.2013.11.100. Epub 2013 Dec 6. No abstract available.

    PMID: 24360155RESULT

  • Tang ZH, Fang Z, Zhou L. Human genetics of diabetic vascular complications. J Genet. 2013 Dec;92(3):677-94. doi: 10.1007/s12041-013-0288-1.

    PMID: 24371189RESULT

  • Zeng F, Tang ZH, Li Z, Yu X, Zhou L. Normative reference of short-term heart rate variability and estimation of cardiovascular autonomic neuropathy prevalence in Chinese people. J Endocrinol Invest. 2014 Apr;37(4):385-91. doi: 10.1007/s40618-013-0047-4. Epub 2014 Jan 9.

    PMID: 24633734RESULT

  • Tang ZH, Zeng F, Li Z, Zhou L. Association and predictive value analysis for resting heart rate and diabetes mellitus on cardiovascular autonomic neuropathy in general population. J Diabetes Res. 2014;2014:215473. doi: 10.1155/2014/215473. Epub 2014 Mar 18.

    PMID: 24772443RESULT

  • Tang ZH, Wang L, Zeng F, Li Z, Yu X, Zhang K, Zhou L. Bayesian estimation of cardiovascular autonomic neuropathy diagnostic test based on short-term heart rate variability without a gold standard. BMJ Open. 2014 Oct 6;4(9):e005096. doi: 10.1136/bmjopen-2014-005096.

    PMID: 25287103RESULT

  • Zhang L, Tang ZH, Zeng F, Li Z, Zhou L, Li Y. Clinical risk model assessment for cardiovascular autonomic dysfunction in the general Chinese population. J Endocrinol Invest. 2015 Jun;38(6):615-22. doi: 10.1007/s40618-014-0229-8. Epub 2015 Jan 3.

    PMID: 25555369RESULT

  • Song L, Zhou L, Tang Z. An association analysis of lipid profile and diabetic cardiovascular autonomic neuropathy in a Chinese sample. Lipids Health Dis. 2016 Jul 26;15:122. doi: 10.1186/s12944-016-0287-3.

    PMID: 27457375DERIVED

  • Ge X, Chen H, Zhang K, Tang ZH. The analysis of blood pressure profiles and their severity in relation to diabetic cardiovascular autonomic neuropathy in the Chinese population: preliminary analysis. J Endocrinol Invest. 2016 Aug;39(8):891-8. doi: 10.1007/s40618-016-0444-6. Epub 2016 Mar 3.

    PMID: 26940214DERIVED

Study Officials

  • Zihui Tang, M.D and Ph.D

    Huashan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D and Ph.D

Study Record Dates

First Submitted

June 1, 2015

First Posted

June 3, 2015

Study Start

January 1, 2013

Primary Completion

August 1, 2018

Study Completion

February 1, 2019

Last Updated

March 20, 2019

Record last verified: 2019-03

Locations

CN(1)