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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01706289
Other study ID # NTUH20090323HRV
Secondary ID
Status Recruiting
Phase N/A
First received October 10, 2012
Last updated October 12, 2012
Start date March 2009
Est. completion date May 2014

Study information

Verified date September 2012
Source National Taiwan University Hospital
Contact Ying-Chuen Lai
Phone 886-02-23123456
Email ying.chuen@msa.hinet.net
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Observational

Clinical Trial Summary

Exploring the relationship between serum VAP-1 and cardiovascular autonomic neuropathy in subjects with type 2 diabetes mellitus


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 10 Years to 90 Years
Eligibility Inclusion Criteria:

- type 2 diabetes mellitus

Exclusion Criteria:

- arrythmia

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms

  • Nervous System Diseases
  • Neuropathy; Peripheral, Autonomic, in Diabetes Mellitus (Manifestation)
  • Peripheral Nervous System Diseases

Locations

Country Name City State
Taiwan National Taiwan University Hospital Yun Lin

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan,