Diabetic Cardiovascular Autonomic Neuropathy Clinical Trial
Official title:
The Risk Analysis for Diabetic Cardiovascular Autonomic Neuropathy in General Chinese Population
| NCT number | NCT02461472 |
| Other study ID # | DCANRA_Dr.Tang |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 2013 |
| Est. completion date | February 2019 |
| Verified date | March 2019 |
| Source | Shanghai Tongji Hospital, Tongji University School of Medicine |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 2000 |
| Est. completion date | February 2019 |
| Est. primary completion date | August 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 30 Years to 90 Years |
| Eligibility |
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). |
| Country | Name | City | State |
|---|---|---|---|
| China | Huasha Hospital | Shanghai | Shanghai |
| Lead Sponsor | Collaborator |
|---|---|
| Shanghai Tongji Hospital, Tongji University School of Medicine | Huashan Hospital |
China,
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. — View Citation
Tang ZH, Fang Z, Zhou L. Human genetics of diabetic vascular complications. J Genet. 2013 Dec;92(3):677-94. Review. — View Citation
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. Prin — View Citation
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-20 — View Citation
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. — View Citation
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 1 — View Citation
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 — View Citation
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. E — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |