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Myocardial Perfusion in Type 2 Diabetes

U

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

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.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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