Myocardial Perfusion in Type 2 Diabetes

January 6, 2010 updated by: University of Sao Paulo General Hospital

Evaluation of Myocardial Perfusion and Microvascular Reserve in Real-time Utilizing Myocardial Contrast Echocardiography in Type 2 Diabetes.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Diabetes
Type 2 diabetes patients without obstructive coronary disease. Interventional group: lifestyle changes and treatment with metformin.
Drug: Metformin
Metformin 850mg
Other Names:
  • Glucophage
No Intervention: Control
Control group - normal, healthy individuals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
myocardial blood flow velocity, myocardial blood flow reserve
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • Study Director: Wilson Mathias Jr, Md, PhD, Heart Institute - Sao Paulo - Brazil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

January 6, 2010

First Submitted That Met QC Criteria

January 6, 2010

First Posted (Estimate)

January 7, 2010

Study Record Updates

Last Update Posted (Estimate)

January 7, 2010

Last Update Submitted That Met QC Criteria

January 6, 2010

Last Verified

August 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0925
  • nata925 (Other Grant/Funding Number: 05/57793-6R)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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