Myocardial Perfusion in Type 2 Diabetes
Overview[ - collapse ][ - ]
| Purpose | 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 | Type 2 Diabetes |
| Intervention | Drug: Metformin |
| Phase | Phase 1/Phase 2 |
| Sponsor | University of Sao Paulo General Hospital |
| Responsible Party | University of Sao Paulo General Hospital |
| ClinicalTrials.gov Identifier | NCT01043965 |
| First Received | January 6, 2010 |
| Last Updated | January 6, 2010 |
| Last verified | August 2005 |
Tracking Information[ + expand ][ + ]
| First Received Date | January 6, 2010 |
|---|---|
| Last Updated Date | January 6, 2010 |
| Start Date | August 2005 |
| Estimated Primary Completion Date | August 2009 |
| Current Primary Outcome Measures | myocardial blood flow velocity, myocardial blood flow reserve [Time Frame: 3 months] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | Myocardial Perfusion in Type 2 Diabetes |
|---|---|
| Official Title | Evaluation of Myocardial Perfusion and Microvascular Reserve in Real-time Utilizing Myocardial Contrast Echocardiography in Type 2 Diabetes. |
| 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 Type | Interventional |
| Study Phase | Phase 1/Phase 2 |
| Study Design | Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic |
| Condition | Type 2 Diabetes |
| Intervention | Drug: Metformin Metformin 850mg Other Names: Glucophage |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 61 |
| Estimated Completion Date | August 2009 |
| Estimated Primary Completion Date | August 2009 |
| Eligibility Criteria | 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 |
| Gender | Both |
| Ages | 30 Years |
| Accepts Healthy Volunteers | Accepts Healthy Volunteers |
| Contacts | Not Provided |
| Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01043965 |
|---|---|
| Other Study ID Numbers | 0925 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | University of Sao Paulo General Hospital |
| Study Sponsor | University of Sao Paulo General Hospital |
| Collaborators | Fundação de Amparo à Pesquisa do Estado de São Paulo |
| Investigators | Study Director: Wilson Mathias Jr, Md, PhD Heart Institute - Sao Paulo - Brazil |
| Verification Date | August 2005 |