Myocardial Perfusion in Type 2 Diabetes

• Sponsor: University of Sao Paulo General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01043965
• Collaborator: Fundação de Amparo à Pesquisa do Estado de São Paulo (Other)
• Enrollment: 61
• Arms: 2
• Duration (Months): 48

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Drug: Metformin	Phase 1/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
• Actual Enrollment: 61 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Investigator)
• Primary Purpose: Diagnostic
• Official Title: Evaluation of Myocardial Perfusion and Microvascular Reserve in Real-time Utilizing Myocardial Contrast Echocardiography in Type 2 Diabetes.
• Study Start Date: Aug 1, 2005
• Actual Primary Completion Date: Aug 1, 2009
• Actual Study Completion Date: Aug 1, 2009

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. myocardial blood flow velocity, myocardial blood flow reserve [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 65 Years
• Sexes Eligible for Study: 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

• COPD

• Cardiac Arrhythmias

• Cardiomyopathy

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Sao Paulo General Hospital
• Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01043965
• Other Study ID Numbers: 0925; nata925
• First Posted: Jan 7, 2010
• Last Update Posted: Jan 7, 2010
• Last Verified: Aug 1, 2005

• Keywords provided by , ,: Diabetes Mellitus; Myocardial perfusion imaging; Heart diseases; Echocardiography; Endothelium
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Metformin

Study Results

No Results Posted as of Jan 7, 2010