- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02461342
Genetic, Environment and Its Interaction Analysis for Cardiovascular Autonomic Neuropathy
September 20, 2016 updated by: Zihui Tang, Shanghai Tongji Hospital, Tongji University School of Medicine
Genetic, Environment and Its Interaction Analysis for Cardiovascular Autonomic Neuropathy in Chinese Population
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
2100
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
-
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Shanghai
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Shanghai, Shanghai, China, 200040
- Huashan Hospital
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Shanghai, Shanghai, China, 200040
- Huasha Hospital
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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 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.
Description
Inclusion Criteria:
- Survey Chinese participants with undiagnosed CAN Aged 30-90 years, were included in this study.
Exclusion Criteria:
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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.
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 genetic, environment and its interaction analysis of human complex disease
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This is a cross-sectional study, no intervention was performed.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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.
Collaborators
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
- 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.
- 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.
- 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.
- 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.
- 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. Erratum In: PLoS One. 2017 Apr 25;12 (4):e0176771.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
January 1, 2011
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
July 1, 2016
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 (Estimate)
September 22, 2016
Last Update Submitted That Met QC Criteria
September 20, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CANGEI_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.
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