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

NCT ID: NCT01706289

Last Updated: 2012-10-15

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2014-05-31

Brief Summary

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

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.

Conditions

Neuropathy; Peripheral, Autonomic, in Diabetes Mellitus (Manifestation)

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

diabetic mellitus screen

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• type 2 diabetes mellitus

Exclusion Criteria

• arrythmia

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hung-Yaun Li

Role: STUDY_CHAIR

National Taiwan University Hospital

Locations

National Taiwan University Hospital

Douliu, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Ying-Chuen Lai

Role: CONTACT

ying.chuen@msa.hinet.net

886-02-23123456 ext. 63678

Facility Contacts

Ying-Chuen Lai

Role: primary

ying.chuen@msa.hinet.net

886-05-5323911 ext. 5125

Other Identifiers

NTUH20090323HRV

Identifier Type: -

Identifier Source: org_study_id