Risk Analysis for Diabetic Cardiovascular Autonomic Neuropathy

NCT ID: NCT02461472

Last Updated: 2019-03-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2019-02-28

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.

Conditions

Diabetic Cardiovascular Autonomic Neuropathy

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Dr.Tang's research group

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

not intervention

Intervention Type: OTHER

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

Interventions

not intervention

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

Intervention Type: OTHER

Other Intervention Names

nothing

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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).

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Huashan Hospital

OTHER

Sponsor Role: collaborator

Shanghai Tongji Hospital, Tongji University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Zihui Tang

M.D and Ph.D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zihui Tang, M.D and Ph.D

Role: PRINCIPAL_INVESTIGATOR

Huashan Hospital

Locations

Huasha Hospital

Shanghai, Shanghai Municipality, China

Countries

China

References

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.

Reference Type: RESULT

PMID: 23770583 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23890865 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23940593 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24360155 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24371189 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24633734 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24772443 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25287103 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25555369 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27457375 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26940214 (View on PubMed)

Other Identifiers

DCANRA_Dr.Tang

Identifier Type: -

Identifier Source: org_study_id