Alteration of Myocardial Deformations in Diabetes: Relationship to Micro-angiopathy

NCT ID: NCT01220349

Last Updated: 2013-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-10-31

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.

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%).

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Echocardiographic 2D strain analysis

Group Type: EXPERIMENTAL

Echocardiographic 2D strain analysis

Intervention Type: DEVICE

Conventional transthoracic echocardiography with acquisitions for strain analysis by speckle tracking (2D strain)

Interventions

Echocardiographic 2D strain analysis

Conventional transthoracic echocardiography with acquisitions for strain analysis by speckle tracking (2D strain)

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patricia REANT, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Bordeaux, France

Locations

Hôpital Cardiologique du Haut-Lévêque, Service de Cardiologie et Maladies Vasculaires

Pessac, , France

Countries

France

Other Identifiers

CHUBX 2009/27

Identifier Type: -

Identifier Source: org_study_id