<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01706289</url>
  </required_header>
  <id_info>
    <org_study_id>NTUH20090323HRV</org_study_id>
    <nct_id>NCT01706289</nct_id>
  </id_info>
  <brief_title>The Relationship Between Vascular Adhesion Protein-1 and Diabetic Cardiovascular Autonomic Neuropathy</brief_title>
  <official_title>The Relationship Between Vascular Adhesion Protein-1 and Diabetic Cardiovascular Autonomic Neuropathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Exploring the relationship between serum VAP-1 and cardiovascular autonomic neuropathy in&#xD;
      subjects with type 2 diabetes mellitus&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The prevalence of diabetes mellitus is increasing recently, especially in the urban area of&#xD;
      developing countries. Subjects with diabetes have higher rate of hospitalization and have&#xD;
      higher mortality. Diabetes results in various complications including diabetic retinopathy,&#xD;
      nephropathy, neuropathy, and cardiovascular complications. Among these, cardiovascular&#xD;
      autonomic neuropathy is one of clinical important complication of diabetes. Diabetic subjects&#xD;
      with reduced cardiovascular autonomic function have been shown to strongly associate with an&#xD;
      increased risk of silent myocardial ischemia and increased mortality. They also have higher&#xD;
      risk of sudden death, intraoperative and perioperative cardiovascular instability. Formation&#xD;
      of advanced glycation end product (AGE) and oxidative stress are important causes of diabetic&#xD;
      neuropathy. Vascular adhesion protein-1 (VAP-1), an adhesion molecule with an activity of&#xD;
      semicarbazide-sensitive amine oxidases (SSAO), which can catalyze endogenous amines to&#xD;
      produces corresponding aldehydes, H2O2, and ammonia. We have demonstrated that serum VAP-1 is&#xD;
      a source of systemic AGE and oxidative stress, and is associated with nephropathy and&#xD;
      atherosclerosis. There are reports demonstrating that subjects with diabetic retinopathy or&#xD;
      stroke have higher serum VAP-1. To our best knowledge, there is no report regarding the&#xD;
      relationship between serum VAP-1 and neuropathy. In present study, we will measure serum&#xD;
      VAP-1 and check cardiovascular autonomic function. We will also explore the relationship&#xD;
      between serum VAP-1 and cardiovascular autonomic neuropathy in subjects with type 2 diabetes&#xD;
      mellitus.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2009</start_date>
  <completion_date type="Anticipated">May 2014</completion_date>
  <primary_completion_date type="Anticipated">May 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Neuropathy; Peripheral, Autonomic, in Diabetes Mellitus (Manifestation)</condition>
  <arm_group>
    <arm_group_label>diabetic mellitus screen</arm_group_label>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      whole blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        type 2 diabetes mellitus&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  type 2 diabetes mellitus&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  arrythmia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hung-Yaun Li</last_name>
    <role>Study Chair</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ying-Chuen Lai</last_name>
    <phone>886-02-23123456</phone>
    <phone_ext>63678</phone_ext>
    <email>ying.chuen@msa.hinet.net</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Yun Lin</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ying-Chuen Lai</last_name>
      <phone>886-05-5323911</phone>
      <phone_ext>5125</phone_ext>
      <email>ying.chuen@msa.hinet.net</email>
    </contact>
    <investigator>
      <last_name>Ying-Chuen Lai</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>October 10, 2012</study_first_submitted>
  <study_first_submitted_qc>October 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <last_update_submitted>October 12, 2012</last_update_submitted>
  <last_update_submitted_qc>October 12, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 15, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>diabetes</keyword>
  <keyword>cardiovascular autonomic neuropathy</keyword>
  <keyword>VAP 1</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Nervous System Diseases</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01706289
org study id: NTUH20090323HRV
nct id: NCT01706289
lead sponsor: 
has dmc: No
Exploring the relationship between serum VAP-1 and cardiovascular autonomic neuropathy in
      subjects with type 2 diabetes mellitus
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.
observational model: Case-Control
time perspective: Prospective
arm group label: diabetic mellitus screen
whole blood
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 10 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hung-Yaun Li
role: Study Chair
affiliation: National Taiwan University Hospital
last name: Ying-Chuen Lai
phone: 886-02-23123456
phone ext: 63678
email: ying.chuen@msa.hinet.net
facility: 
status: Recruiting
contact: 
investigator: 
country: Taiwan
responsible party type: Sponsor
mesh term: Peripheral Nervous System Diseases