Myocardial Perfusion in Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01043965
First received: January 6, 2010
Last updated: NA
Last verified: August 2005
History: No changes posted
  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 Intervention Phase
Type 2 Diabetes
Drug: Metformin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Evaluation of Myocardial Perfusion and Microvascular Reserve in Real-time Utilizing Myocardial Contrast Echocardiography in Type 2 Diabetes.

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • myocardial blood flow velocity, myocardial blood flow reserve [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 61
Study Start Date: August 2005
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Wilson Mathias Jr, Heart Institute - Sao Paulo - Brazil
ClinicalTrials.gov Identifier: NCT01043965     History of Changes
Other Study ID Numbers: 0925, nata925
Study First Received: January 6, 2010
Last Updated: January 6, 2010
Health Authority: Brazil: Ethics Committee

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

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

ClinicalTrials.gov processed this record on September 18, 2014