NCT02461342

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,100

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

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, 2011

Completed
4.4 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
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

September 22, 2016

Status Verified

September 1, 2016

Enrollment Period

5.4 years

First QC Date

June 1, 2015

Last Update Submit

September 20, 2016

Conditions

Cardiovascular Autonomic Neuropathy

Keywords

Geneticenvironmentinteraction analysiscardiovascular autonomic neuropathyCAN

Outcome Measures

Primary Outcomes (1)

  • cardiovascular autonomic neuropathy (CAN) measured by 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 genetic, environment and its interaction 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 participants with undiagnosed CAN, aged 30-90 years, were included in this study. Our study invited a total of 3,012 subjects to a screening visit between 2011 and 2012.

You may qualify if:

  • Survey Chinese participants with undiagnosed CAN 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). Of these subjects, complete baseline data were obtained for 2,092 (69.46%) of the participants.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Huasha Hospital

Shanghai, Shanghai Municipality, 200040, China

Location

Huashan Hospital

Shanghai, Shanghai Municipality, 200040, China

Location

Related Publications (14)

  • Liao XP, Zhu HW, Zeng F, Tang ZH. The association and interaction analysis of hypertension and uric acid on cardiovascular autonomic neuropathy. J Endocrinol Invest. 2015 Oct;38(10):1075-82. doi: 10.1007/s40618-015-0291-x. Epub 2015 Apr 23.

    PMID: 25903694RESULT

  • Tang ZH, Zeng F, Zhang XZ. Human genetics of diabetic nephropathy. Ren Fail. 2015 Apr;37(3):363-71. doi: 10.3109/0886022X.2014.1000801. Epub 2015 Jan 16.

    PMID: 25594612RESULT

  • 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

  • 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

  • Tang ZH, Wang L, Zeng F, Zhang K. Human genetics of diabetic retinopathy. J Endocrinol Invest. 2014 Dec;37(12):1165-74. doi: 10.1007/s40618-014-0172-8. Epub 2014 Sep 9.

    PMID: 25201002RESULT

  • 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

  • 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, 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, 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, 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

  • 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, 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

  • Lv Y, Zhou L, Tang Z, Dong J. Association and interaction analysis of diabetes mellitus and SCN10A for cardiovascular autonomic neuropathy in a Chinese population. Postgrad Med J. 2017 Jun;93(1100):344-348. doi: 10.1136/postgradmedj-2016-134202. Epub 2016 Oct 11.

    PMID: 27729462DERIVED

  • Zeng F, Zhou L, Tang Z. A study for association and interaction analysis to metabolic syndrome and the ESR1 gene on cardiovascular autonomic neuropathy in a Chinese Han population. Diabetol Metab Syndr. 2016 Jul 22;8:42. doi: 10.1186/s13098-016-0155-3. eCollection 2016.

    PMID: 27453734DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

DNAs were extracted and genetyped by using SNP.

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, 2011

Primary Completion

June 1, 2016

Study Completion

July 1, 2016

Last Updated

September 22, 2016

Record last verified: 2016-09

Locations

CN(2)