- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01706289
The Relationship Between Vascular Adhesion Protein-1 and Diabetic Cardiovascular Autonomic Neuropathy
October 12, 2012 updated by: National Taiwan University Hospital
Exploring the relationship between serum VAP-1 and cardiovascular autonomic neuropathy in subjects with type 2 diabetes mellitus
Study Overview
Status
Unknown
Detailed Description
The prevalence of diabetes mellitus is increasing recently, especially in the urban area of developing countries.
Subjects with diabetes have higher rate of hospitalization and have higher mortality.
Diabetes results in various complications including diabetic retinopathy, nephropathy, neuropathy, and cardiovascular complications.
Among these, cardiovascular autonomic neuropathy is one of clinical important complication of diabetes.
Diabetic subjects with reduced cardiovascular autonomic function have been shown to strongly associate with an increased risk of silent myocardial ischemia and increased mortality.
They also have higher risk of sudden death, intraoperative and perioperative cardiovascular instability.
Formation of advanced glycation end product (AGE) and oxidative stress are important causes of diabetic neuropathy.
Vascular adhesion protein-1 (VAP-1), an adhesion molecule with an activity of semicarbazide-sensitive amine oxidases (SSAO), which can catalyze endogenous amines to produces corresponding aldehydes, H2O2, and ammonia.
We have demonstrated that serum VAP-1 is a source of systemic AGE and oxidative stress, and is associated with nephropathy and atherosclerosis.
There are reports demonstrating that subjects with diabetic retinopathy or stroke have higher serum VAP-1.
To our best knowledge, there is no report regarding the relationship between serum VAP-1 and neuropathy.
In present study, we will measure serum VAP-1 and check cardiovascular autonomic function.
We will also explore the relationship between serum VAP-1 and cardiovascular autonomic neuropathy in subjects with type 2 diabetes mellitus.
Study Type
Observational
Enrollment (Anticipated)
150
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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Yun Lin, Taiwan
- Recruiting
- National Taiwan University Hospital
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Contact:
- Ying-Chuen Lai
- Phone Number: 5125 886-05-5323911
- Email: ying.chuen@msa.hinet.net
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Principal Investigator:
- Ying-Chuen Lai
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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
10 years to 90 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
type 2 diabetes mellitus
Description
Inclusion Criteria:
- type 2 diabetes mellitus
Exclusion Criteria:
- arrythmia
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 |
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diabetic mellitus screen
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Hung-Yaun Li, National Taiwan University Hospital
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
March 1, 2009
Primary Completion (Anticipated)
May 1, 2014
Study Completion (Anticipated)
May 1, 2014
Study Registration Dates
First Submitted
October 10, 2012
First Submitted That Met QC Criteria
October 12, 2012
First Posted (Estimate)
October 15, 2012
Study Record Updates
Last Update Posted (Estimate)
October 15, 2012
Last Update Submitted That Met QC Criteria
October 12, 2012
Last Verified
September 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NTUH20090323HRV
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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