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The Relationship Between Vascular Adhesion Protein-1 and Diabetic Cardiovascular Autonomic Neuropathy

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ClinicalTrials.gov Identifier: NCT01706289
Recruitment Status : Unknown
Verified September 2012 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : October 15, 2012
Last Update Posted : October 15, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Exploring the relationship between serum VAP-1 and cardiovascular autonomic neuropathy in subjects with type 2 diabetes mellitus

Condition or disease
Neuropathy; Peripheral, Autonomic, in Diabetes Mellitus (Manifestation)

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 Design

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Relationship Between Vascular Adhesion Protein-1 and Diabetic Cardiovascular Autonomic Neuropathy
Study Start Date : March 2009
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : May 2014
Groups and Cohorts

Group/Cohort
diabetic mellitus screen


Outcome Measures

Biospecimen Retention:   Samples With DNA
whole blood

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 90 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
type 2 diabetes mellitus
Criteria

Inclusion Criteria:

  • type 2 diabetes mellitus

Exclusion Criteria:

  • arrythmia
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01706289


Contacts
Contact: Ying-Chuen Lai 886-02-23123456 ext 63678 ying.chuen@msa.hinet.net

Locations
Taiwan
National Taiwan University Hospital Recruiting
Yun Lin, Taiwan
Contact: Ying-Chuen Lai    886-05-5323911 ext 5125    ying.chuen@msa.hinet.net   
Principal Investigator: Ying-Chuen Lai         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Study Chair: Hung-Yaun Li National Taiwan University Hospital
More Information

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01706289     History of Changes
Other Study ID Numbers: NTUH20090323HRV
First Posted: October 15, 2012    Key Record Dates
Last Update Posted: October 15, 2012
Last Verified: September 2012

Keywords provided by National Taiwan University Hospital:
diabetes
cardiovascular autonomic neuropathy
VAP 1

Additional relevant MeSH terms:
Diabetes Mellitus
Peripheral Nervous System Diseases
Nervous System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Neuromuscular Diseases