Alteration of Myocardial Deformations in Diabetes: Relationship to Micro-angiopathy (ECHO-DIAB)
Primary Purpose
Diabetes Mellitus, Type 1
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Echocardiographic 2D strain analysis
Sponsored by
About this trial
This is an interventional diagnostic trial for Diabetes Mellitus, Type 1
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.
Sites / Locations
- Hôpital Cardiologique du Haut-Lévêque, Service de Cardiologie et Maladies Vasculaires
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Echocardiographic 2D strain analysis
Arm Description
Outcomes
Primary Outcome Measures
Measurement of the alteration of left ventricular myocardial strain (≤ 18% in absolute value) by echocardiography and the relationship to micro-angiopathy.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01220349
First Posted
October 7, 2010
Last Updated
April 18, 2013
Sponsor
University Hospital, Bordeaux
1. Study Identification
Unique Protocol Identification Number
NCT01220349
Brief Title
Alteration of Myocardial Deformations in Diabetes: Relationship to Micro-angiopathy
Acronym
ECHO-DIAB
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 Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
4. Oversight
Data Monitoring Committee
No
5. Study Description
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%).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Echocardiographic 2D strain analysis
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Echocardiographic 2D strain analysis
Intervention Description
Conventional transthoracic echocardiography with acquisitions for strain analysis by speckle tracking (2D strain)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia REANT, MD-PhD
Organizational Affiliation
University Hospital Bordeaux, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Cardiologique du Haut-Lévêque, Service de Cardiologie et Maladies Vasculaires
City
Pessac
ZIP/Postal Code
33604
Country
France
12. IPD Sharing Statement
Learn more about this trial
Alteration of Myocardial Deformations in Diabetes: Relationship to Micro-angiopathy
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