Myocardial Perfusion in Type 2 Diabetes

University of Sao Paulo General Hospital

Status and phase: Completed; Phase 2; Phase 1

Conditions: Type 2 Diabetes

Treatments: Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT01043965

nata925 (Other Grant/Funding Number)

0925

Details and patient eligibility

About

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).

Full 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.

Enrollment: 61 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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61 participants in 2 patient groups

Diabetes

Active Comparator group

Description:

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

Treatment:

Drug: Metformin

Control

No Intervention group

Description:

Control group - normal, healthy individuals.