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

NCT01220349 | Completed

• 1 other identifier: CHUBX 2009/27
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• Measurement of the alteration of left ventricular myocardial strain (≤ 18% in absolute value) by echocardiography and the relationship to micro-angiopathy.

  Inclusion : Day 1

Secondary Outcomes (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.

  Inclusion : Day 1

Study Arms (1)

Echocardiographic 2D strain analysis

EXPERIMENTAL

Device: Echocardiographic 2D strain analysis

Interventions

Echocardiographic 2D strain analysis DEVICE

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

Echocardiographic 2D strain analysis

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• aged between 18 and 45 years
• with diagnosed Type 1 diabetes mellitus (with or without complications or peripheric vascular micro-angiopathy)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

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

Pessac, 33604, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Patricia REANT, MD-PhD

  University Hospital Bordeaux, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2010
• First Posted: October 13, 2010
• Study Start: January 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: April 19, 2013

Record last verified: 2013-04

Locations

FR (1)