Alteration of Myocardial Deformations in Diabetes: Relationship to Micro-angiopathy (ECHO-DIAB)

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. Identifier: NCT01220349
Recruitment Status : Completed
First Posted : October 13, 2010
Last Update Posted : April 19, 2013
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief Summary:
Despite careful monitoring of patients with diabetes, it is so far difficult to predict the occurrence of cardiac events in the evolution. As shown by various studies conducted in patients with diabetes, cardiac involvement can be detected by abnormalities of diastolic or systolic functions using non-invasive investigations such as echocardiography. For 4 years, the evaluation technique of myocardial deformations by two-dimensional speckle tracking strain by echocardiography is the subject of high hopes in the earlier detection of still asymptomatic cardiomyopathies. In the present study, the investigators hypothesized that this technique would improve the detection of myocardial contraction abnormalities in patients with insulin-dependent diabetes mellitus (IDDM), and would establish their association with micro-angiopathy, frequently encountered in these patients.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Device: Echocardiographic 2D strain analysis Not Applicable

Detailed Description:

This is a single center case-control study based on routine care, designed to recruit patients with type 1 diabetes mellitus free from any other myocardiopathy. The inclusion will take place over a period of 24 months. No monitoring of patients (no follow-up) is provided under this protocol. The analysis will focus on the combination of the left ventricle myocardial deformations alteration revealed by the echocardiographic 2D strain analysis (< 18% in absolute value), with the existence of micro-angiopathy in type 1 diabetes mellitus patients with preserved left ventricular ejection fraction ( ≥ 60%).

Two hundred subjects with type 1 diabetes mellitus will be recruited: 100 subjects with impaired left ventricular myocardial deformation by 2D strain analysis (< 18% in absolute value), constituting the 'cases' group and 100 subjects without alteration in myocardial deformation (global strain ≥ 18%).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Early Detection of Diabetic Cardiomyopathy by Analysis of Myocardial Deformations by Two-dimensional Speckle Tracking Strain Echocardiography and Relationship to Micro-angiopathy
Study Start Date : January 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Echocardiographic 2D strain analysis Device: Echocardiographic 2D strain analysis
Conventional transthoracic echocardiography with acquisitions for strain analysis by speckle tracking (2D strain)

Primary Outcome Measures :
  1. Measurement of the alteration of left ventricular myocardial strain (≤ 18% in absolute value) by echocardiography and the relationship to micro-angiopathy. [ Time Frame: Inclusion : Day 1 ]

Secondary Outcome Measures :
  1. Analyses of this association (alteration of myocardial strain and micro-angiopathy) in relation with the duration of diabetes, and other co-factors such as dyslipidemia, unstable diabetes, and coexisting macro-angiopathy. [ Time Frame: Inclusion : Day 1 ]

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • aged between 18 and 45 years
  • with diagnosed Type 1 diabetes mellitus (with or without complications or peripheric vascular micro-angiopathy)
  • having a negative myocardial ischemic test (exercise echocardiography) in the previous month inclusion

Exclusion Criteria:

  • Known or suspected coronary artery disease
  • atrial fibrillation
  • hypertension
  • moderate to severe valvular disease
  • sequelae of myocardial infarction
  • secondary or primary cardiomyopathy
  • myocardial conduction abnormalities
  • pregnancy or breastfeeding.

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 identifier (NCT number): NCT01220349

Hôpital Cardiologique du Haut-Lévêque, Service de Cardiologie et Maladies Vasculaires
Pessac, France, 33604
Sponsors and Collaborators
University Hospital, Bordeaux
Principal Investigator: Patricia REANT, MD-PhD University Hospital Bordeaux, France

Responsible Party: University Hospital, Bordeaux Identifier: NCT01220349     History of Changes
Other Study ID Numbers: CHUBX 2009/27
First Posted: October 13, 2010    Key Record Dates
Last Update Posted: April 19, 2013
Last Verified: April 2013

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases