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Clinical Trials/NCT01043965
NCT01043965
Completed
Phase 1

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

University of Sao Paulo General Hospital0 sites61 target enrollmentStarted: August 2005Last updated:
ConditionsType 2 Diabetes
InterventionsMetformin

Overview

Phase
Phase 1
Status
Completed
Enrollment
61
Primary Endpoint
myocardial blood flow velocity, myocardial blood flow reserve

Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
Single (Investigator)

Eligibility Criteria

Ages
30 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

Diabetes

Active Comparator

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

Intervention: Metformin (Drug)

Outcomes

Primary Outcomes

myocardial blood flow velocity, myocardial blood flow reserve

Time Frame: 3 months

Secondary Outcomes

No secondary outcomes reported

Investigators

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