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Efficacy of Administration of ACE-Inhibition on Autonomic and Peripheral Neuropathy in Patients With Diabetes Mellitus

Primary Purpose

Diabetic Autonomic Neuropathy

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Quinapril
Sponsored by
Aristotle University Of Thessaloniki
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional trial for Diabetic Autonomic Neuropathy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All Sexes

Inclusion Criteria:

  • Diabetes mellitus with both autonomic and peripheral neuropathy

Exclusion Criteria:

  • Hypertension, coronary heart disease

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Changes in R-R variation during deep breathing
    Changes in response to Valsalva maneuver
    Changes in 30:15 ratio
    Changes in blood pressure response to standing

    Secondary Outcome Measures

    Full Information

    First Posted
    January 12, 2017
    Last Updated
    January 24, 2017
    Sponsor
    Aristotle University Of Thessaloniki
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03031834
    Brief Title
    Efficacy of Administration of ACE-Inhibition on Autonomic and Peripheral Neuropathy in Patients With Diabetes Mellitus
    Official Title
    Efficacy of Administration of Angiotensin Converting Enzyme Inhibition on Autonomic and Peripheral Neuropathy in Patients With Diabetes Mellitus
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1999 (undefined)
    Primary Completion Date
    May 2001 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Aristotle University Of Thessaloniki

    4. Oversight

    5. Study Description

    Brief Summary
    Patients with diabetes mellitus and definite autonomic and peripheral neuropathy were randomized to receive quinapril or no treatment for 2 years.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetic Autonomic Neuropathy

    7. Study Design

    Study Phase
    Phase 4

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Quinapril
    Primary Outcome Measure Information:
    Title
    Changes in R-R variation during deep breathing
    Time Frame
    2 years
    Title
    Changes in response to Valsalva maneuver
    Time Frame
    2 years
    Title
    Changes in 30:15 ratio
    Time Frame
    2 years
    Title
    Changes in blood pressure response to standing
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Eligibility Criteria
    Inclusion Criteria: Diabetes mellitus with both autonomic and peripheral neuropathy Exclusion Criteria: Hypertension, coronary heart disease

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Efficacy of Administration of ACE-Inhibition on Autonomic and Peripheral Neuropathy in Patients With Diabetes Mellitus

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