Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05071157 |
| Other study ID # |
RBHP 2018 PAYSAL |
| Secondary ID |
2018-A01907-48 |
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 6, 2019 |
| Est. completion date |
January 31, 2020 |
Study information
| Verified date |
January 2023 |
| Source |
University Hospital, Clermont-Ferrand |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The study aims to better understand the functioning of the heart of children and adolescents
with anorexia nervosa or obesity, compared to the heart function of control subject. This
project seeks to find out if a weight disorder affects the heart and whether a systematic
cardiac assessment with appropriate management is then to be considered.
To meet this objective, several analyzes are planned including a speckle tracking
echocardiography, allowing a non-invasive study of myocardial deformations.
The hypothesis is that two opposite weight disorders (anorexia nervosa and obesity) lead to
similar complications: inflammation, fibrosis altering the myocardial structure and therefore
its contractility. Both systolic and diastolic dysfunction appear. Investigator hypothesize
that the determinants of this dysfunction involve part of the alteration of body mass, and
partly qualitative alterations specific to each pathology.
Description:
The main objective is to evaluate the cardiac dysfunctions through the study of myocardial
deformities in anorexic and obese adolescents, in comparison with controls. The choice of a
pediatric population is explained by the probable precocity of the cardiac repercussions of
these weight disorders. The desire to bring together in the same study two opposite weight
disorders is because a certain number of complications are common to both: repercussions on
the cardiac mass, presence of chronic systemic inflammation, and fibrosis. Comparison to
normo-weighted healthy subjects will make it possible to determine whether certain
alterations are directly attributable to body composition (in the case of a continuum of a
parameter between the three groups) or, on the contrary, independent of body composition.
The search for the mechanisms at the origin of these alterations represents our secondary
objective. For this, a correlation of the cardiac parameters with several factors such as:
duration and severity of disorders, body composition, heart mass, presence of myocardial
fibrosis, epicardial fat level, sympatho-vagal balance (by the cardiac variability), systemic
inflammatory profile and potential pathways signaling involved (metabolomic analysis) will be
carried out. All these parameters may impact cardiac function.
Adolescent girls participating in the study will benefit from a clinical examination with fat
/ lean body mass measurement by impedance, assessment of heart rate variability, blood test
(inflammation marker, metabolomic analysis) and ultrasound heart. Thus, screening for heart
disease, and more generally complications of their pathology, will be performed.
This project is important to answer the question of the necessity or not of a systematic
cardiac assessment in these adolescents and the setting up of an adapted care
