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Myocardial Perfusion in Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT01043965
Recruitment Status : Completed
First Posted : January 7, 2010
Last Update Posted : January 7, 2010
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Sao Paulo General Hospital

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 Type : Interventional  (Clinical Trial)
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 : August 2005
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine


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 Name: Glucophage

No Intervention: Control
Control group - normal, healthy individuals.



Primary Outcome Measures :
  1. myocardial blood flow velocity, myocardial blood flow reserve [ Time Frame: 3 months ]


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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01043965


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

Responsible Party: Wilson Mathias Jr, Heart Institute - Sao Paulo - Brazil
ClinicalTrials.gov Identifier: NCT01043965     History of Changes
Other Study ID Numbers: 0925
nata925 ( Other Grant/Funding Number: 05/57793-6R )
First Posted: January 7, 2010    Key Record Dates
Last Update Posted: January 7, 2010
Last Verified: August 2005

Keywords provided by University of Sao Paulo General Hospital:
Diabetes Mellitus
Myocardial perfusion imaging
Heart diseases
Echocardiography
Endothelium

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs