<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/NCT03031834</url>
  </required_header>
  <id_info>
    <org_study_id>AristotleUMEDSCH095</org_study_id>
    <nct_id>NCT03031834</nct_id>
  </id_info>
  <brief_title>Efficacy of Administration of ACE-Inhibition on Autonomic and Peripheral Neuropathy in Patients With Diabetes Mellitus</brief_title>
  <official_title>Efficacy of Administration of Angiotensin Converting Enzyme Inhibition on Autonomic and Peripheral Neuropathy in Patients With Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aristotle University Of Thessaloniki</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aristotle University Of Thessaloniki</source>
  <brief_summary>
    <textblock>
      Patients with diabetes mellitus and definite autonomic and peripheral neuropathy were&#xD;
      randomized to receive quinapril or no treatment for 2 years.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 1999</start_date>
  <primary_completion_date type="Actual">May 2001</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <primary_outcome>
    <measure>Changes in R-R variation during deep breathing</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in response to Valsalva maneuver</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in 30:15 ratio</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in blood pressure response to standing</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <condition>Diabetic Autonomic Neuropathy</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Quinapril</intervention_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diabetes mellitus with both autonomic and peripheral neuropathy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hypertension, coronary heart disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>January 24, 2017</last_update_submitted>
  <last_update_submitted_qc>January 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aristotle University Of Thessaloniki</investigator_affiliation>
    <investigator_full_name>Konstantinos Tziomalos</investigator_full_name>
    <investigator_title>Assistant Professor of Internal Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Nervous System Diseases</mesh_term>
    <mesh_term>Diabetic Neuropathies</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Quinapril</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03031834
org study id: AristotleUMEDSCH095
nct id: NCT03031834
lead sponsor: 
Patients with diabetes mellitus and definite autonomic and peripheral neuropathy were
      randomized to receive quinapril or no treatment for 2 years.
measure: Changes in R-R variation during deep breathing
time frame: 2 years
measure: Changes in response to Valsalva maneuver
time frame: 2 years
measure: Changes in 30:15 ratio
time frame: 2 years
measure: Changes in blood pressure response to standing
time frame: 2 years
intervention type: Drug
intervention name: Quinapril
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
responsible party type: Principal Investigator
investigator affiliation: Aristotle University Of Thessaloniki
investigator full name: Konstantinos Tziomalos
investigator title: Assistant Professor of Internal Medicine
mesh term: Peripheral Nervous System Diseases
mesh term: Diabetic Neuropathies
mesh term: Diabetes Mellitus
mesh term: Quinapril
sharing ipd: No