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

U

University Hospital of Bordeaux

Status

Completed

Conditions

Diabetes Mellitus, Type 1

Treatments

Device: Echocardiographic 2D strain analysis

Study type

Interventional

Funder types

Other

Identifiers

NCT01220349
CHUBX 2009/27

Details and patient eligibility

About

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.

Full 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%).

Enrollment

61 patients

Sex

All

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

61 participants in 1 patient group

Echocardiographic 2D strain analysis
Experimental group
Treatment:
Device: Echocardiographic 2D strain analysis

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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