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Myocardial Perfusion in Type 2 Diabetes

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Metformin
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Type 2 Diabetes focused on measuring Diabetes Mellitus, Myocardial perfusion imaging, Heart diseases, Echocardiography, Endothelium

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Type 2 diabetes mellitus
  • Normal echocardiogram
  • Absence of obstructive epicardial coronary disease

Exclusion Criteria:

  • Obstructive coronary disease
  • Heart valve disease
  • COPD
  • Cardiac Arrhythmias
  • Cardiomyopathy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Diabetes

    Control

    Arm Description

    Type 2 diabetes patients without obstructive coronary disease. Interventional group: lifestyle changes and treatment with metformin.

    Control group - normal, healthy individuals.

    Outcomes

    Primary Outcome Measures

    myocardial blood flow velocity, myocardial blood flow reserve

    Secondary Outcome Measures

    Full Information

    First Posted
    January 6, 2010
    Last Updated
    January 6, 2010
    Sponsor
    University of Sao Paulo General Hospital
    Collaborators
    Fundação de Amparo à Pesquisa do Estado de São Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01043965
    Brief Title
    Myocardial Perfusion in Type 2 Diabetes
    Official Title
    Evaluation of Myocardial Perfusion and Microvascular Reserve in Real-time Utilizing Myocardial Contrast Echocardiography in Type 2 Diabetes.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2005
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2005 (undefined)
    Primary Completion Date
    August 2009 (Actual)
    Study Completion Date
    August 2009 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Sao Paulo General Hospital
    Collaborators
    Fundação de Amparo à Pesquisa do Estado de São Paulo

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The investigators aimed to evaluate microvascular circulation with novel method: real-time myocardial contrast echocardiography in patients with type 2 diabetes and normal coronary arteries. Myocardial blood flow reserve will be determined by quantitative contrast Stress echocardiography. Diabetic individuals will be evaluate in a decompensated state (Phase 1) and after optimization of medical treatment four months later (Phase 2).
    Detailed Description
    Early stages of epicardial atherosclerosis in patients with type 2 diabetes are associated with an impairment in endothelium-dependent dilation of the coronary microvasculature, indicating that the pathophysiological consequences of atherosclerosis may extend into the coronary microcirculation. The investigators will evaluate three parameters of myocardial quantification with contrast Stress echocardiography and correlate with HbA1C levels.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 2 Diabetes
    Keywords
    Diabetes Mellitus, Myocardial perfusion imaging, Heart diseases, Echocardiography, Endothelium

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    Investigator
    Allocation
    Non-Randomized
    Enrollment
    61 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Diabetes
    Arm Type
    Active Comparator
    Arm Description
    Type 2 diabetes patients without obstructive coronary disease. Interventional group: lifestyle changes and treatment with metformin.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Control group - normal, healthy individuals.
    Intervention Type
    Drug
    Intervention Name(s)
    Metformin
    Other Intervention Name(s)
    Glucophage
    Intervention Description
    Metformin 850mg
    Primary Outcome Measure Information:
    Title
    myocardial blood flow velocity, myocardial blood flow reserve
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Type 2 diabetes mellitus Normal echocardiogram Absence of obstructive epicardial coronary disease Exclusion Criteria: Obstructive coronary disease Heart valve disease COPD Cardiac Arrhythmias Cardiomyopathy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wilson Mathias Jr, Md, PhD
    Organizational Affiliation
    Heart Institute - Sao Paulo - Brazil
    Official's Role
    Study Director

    12. IPD Sharing Statement

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    Myocardial Perfusion in Type 2 Diabetes

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