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Diabetic Cardiovascular Autonomic NeuropathyNCT02461472

Risk Analysis for Diabetic Cardiovascular Autonomic Neuropathy

An observational study of Diabetic Cardiovascular Autonomic Neuropathy, run by Shanghai Tongji Hospital, Tongji University School of Medicine at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 90 yearsHealthy volunteers can take part
What is being tested?
not intervention
How many people
2,000 participants
Where
1 siteChina
Study dates
Jan 2013to Feb 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Huasha Hospital

    Shanghai, Shanghai Municipality, 200040

Other trials in China

About this study

Official title: The Risk Analysis for Diabetic Cardiovascular Autonomic Neuropathy in General 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.

Read the 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.

Being tested
not intervention
Keywords
risk factors, risk analysis, diabetic cardiovascular autonomic neuropathy, general Chinese population

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • not interventionOther

    Also called nothing

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

Study groups in NCT02461472
Study groupRoleWhat they receive
Dr.Tang's research groupDr.Tang's research group for clinical risk analysis of human complex disease
Receives: Other: not intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardiovascular Autonomic Neuropathy (CAN) measured by short-term short-term heart rate variability (HRV)

    Measured: participants will be measured for the duration of outpatient stay, an expected average of 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2015 (estimated)
  2. Study startJan 2013
  3. Primary completionAug 2018
  4. Study completionFeb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02461472
Sponsor's protocol ID
DCANRA_Dr.Tang
Status last verified
Mar 2019
First submitted
1 Jun 2015
Last updated
20 Mar 2019
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 23770583

  • 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.

    PubMed 23890865

  • 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.

    PubMed 23940593

  • 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.

    PubMed 24360155

  • 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.

    PubMed 24371189

  • 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.

    PubMed 24633734

  • 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.

    PubMed 24772443

  • 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.

    PubMed 25287103

  • 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.

    PubMed 25555369

  • 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.

    PubMed 27457375

  • 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.

    PubMed 26940214

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetic Cardiovascular Autonomic Neuropathy, run by Shanghai Tongji Hospital, Tongji University School of Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiovascular Autonomic Neuropathy (CAN) measured by short-term short-term heart rate variability (HRV) (time frame: participants will be measured for the duration of outpatient stay, an expected average of 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02461472, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2019.

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