Myocardial Regional Function by Dobutamine Stress Echocardiography in the Metabolic Syndrome and Type 2 Diabetes

January 17, 2019 updated by: University of Avignon

Comprehensive Analysis of Regional Myocardial Function in Response to Dobutamine Stress in Metabolic Syndrome and Type 2 Diabetic Patients. Effect of Cardiac Adiposity, Inflammation and Hyperglycaemia

Summary.

Theoretical Rationale:

The left ventricular myocardial performance results from a complex interplay between linear deformations (longitudinal, circumferential and radial) and twist/ untwist mechanics. These components of myocardial mechanics can be assessed, at rest and during stress conditions, by high resolution echocardiography using the "2D-strain" technology and constitute good indexes of tissue intrinsic contractility / relaxation properties. Type 2 diabetes (T2DM) and metabolic syndrome (MS) are associated with an increased risk for cardiac diseases. While several clinical studies have reported, particularly in T2DM, a diastolic dysfunction (concept of "diabetic cardiomyopathy"), the existence of impaired regional myocardial function, with altered intrinsic contractility properties, remains largely unanswered, especially in the SM. Stress echocardiography is very interesting to reveal myocardial dysfunction, discrete or absent at rest. To the best of our knowledge, no scientific study is, however, today available on the kinetics of linear strains and twist/untwist dynamics in response to stress in T2DM as well as SM. The epicardial adipose tissue is the source of production of important pro-inflammatory cytokines that have the potential, through an exacerbation of oxidative stress, to impair coronary endothelial function, increase fibrosis, but also directly affect cardiomyocyte calcium homeostasis. An increase in epicardial adipose tissue is consensually reported in T2DM and SM and is clearly associated with coronary atherosclerosis. A link between cardiac adiposity and overall cardiac function, particularly diastolic, is now suggested but to our knowledge no study has challenged its association with myocardial dysfunction in T2DM as SM patients.

Objectives and Methodology: - To investigate regional myocardial linear deformations and torsion, at rest and in response to a dobutamine stress, in asymptomatic T2DM and SM patients without clinical complications, - to study the links between expected regional myocardial abnormalities and inflammation, hyperglycemia and cardiac adiposity. A control group of healthy individuals matched for sex and age will also be included.

All the subjects will benefit from a clinical, anthropometric and biological evaluation. In addition, conventional echocardiography (remodelling and global diastolic and systolic functions) complemented by a functional analysis by tissue Doppler imaging will be performed. Furthermore, 2D cine loops will be recorded in the apical 4, 3 and 2- chamber views for the objective assessment of myocardial longitudinal deformations as well as in the parasternal short axis (base and apex) for the evaluation of the circumferential deformations and basal and apical rotations and left ventricular torsion, at rest and under low dose of dobutamine (110 and 120 bpm).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

125

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Paca
      • Avignon, Paca, France, 84000
        • Hospital Henri Duffaut

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female 40-65 years old, asymptomatic and free of coronary disease

Exclusion Criteria:

  • for all the subjects :
  • body mass index > 35 kg / m2, defining severe obesity,
  • Under insulin therapy,
  • Poorly controlled hypertension (> 140/95)
  • Peripheral vascular disease (> stage II of Leriche)
  • Heart disease or known coronary artery disease,
  • Known and poorly compensated thyroid dysfunction,
  • Nocturnal apnea syndrome,
  • Inability to give written informed consent,
  • Chronic diseases,
  • moderate to severe left ventricular hypertrophy :> 109 g / m2 in women and> 132 g / m2 in men and parietal thickness > 13mm.

for the diabetic patients only :

  • poor glycemic control (HbA1c > 9%)
  • severe autonomic or peripheral neuropathy,
  • Severe diabetic retinopathy,
  • Advanced Diabetic nephropathy (defined by documented proteinuria and / or renal failure).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Type 2 diabetic patients
Regional myocardial function will be assessed during dobutamine stress echocardiography in asymptomatic patients with type II diabetes (according to the American Diabetes Association, 2012) free of coronary diseases.
Drug: dobutamine
In each participant, dobutamine will be administered via intravenous infusion in doses of 10, 20, 30 and 40 lg/kg/min during 3-min stages and 2D strain echocardiography will be performed at each stage.
Experimental: Metabolic syndrom
Regional myocardial function will be assessed during dobutamine stress echocardiography in asymptomatic patients with the Metabolic syndrome (according to Alberti et al 2009) free of diabetes and coronary diseases.
Drug: dobutamine
In each participant, dobutamine will be administered via intravenous infusion in doses of 10, 20, 30 and 40 lg/kg/min during 3-min stages and 2D strain echocardiography will be performed at each stage.
Experimental: controls
Regional myocardial function will be assessed during dobutamine stress echocardiography in healthy subjects.
Drug: dobutamine
In each participant, dobutamine will be administered via intravenous infusion in doses of 10, 20, 30 and 40 lg/kg/min during 3-min stages and 2D strain echocardiography will be performed at each stage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Regional longitudinal strain
Time Frame: day 1
Regional myocardial function will be evaluated for each participant at rest and during low dose dobutamine within a single session.
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Avignon

Investigators

  • Study Director: Philippe Obert, PhD, Laboratory of Cardiovascular Pharm-Ecology, Faculty of Health and Sciences, university of Avignon, 33 rue louis pasteur 84000 Avignon, France.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

July 3, 2015

First Submitted That Met QC Criteria

July 20, 2015

First Posted (Estimate)

July 22, 2015

Study Record Updates

Last Update Posted (Actual)

January 18, 2019

Last Update Submitted That Met QC Criteria

January 17, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UAPV-022015-SFC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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