Myocardial Perfusion in Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01043965
• Other study ID #: 0925
• Secondary ID: nata925
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 6, 2010
• Last updated: January 6, 2010
• Start date: August 2005
• Est. completion date: August 2009

Study information

• Verified date: August 2005
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Metformin
Metformin 850mg

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Fundação de Amparo à Pesquisa do Estado de São Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	myocardial blood flow velocity, myocardial blood flow reserve		3 months	No