We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Myocardial Perfusion in Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01043965
Recruitment Status : Completed
First Posted : January 7, 2010
Last Update Posted : January 7, 2010
Information provided by:

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  (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
Primary Completion Date : August 2009
Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   30 Years to 65 Years   (Adult)
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

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

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

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