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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


Recruitment information / eligibility

Status Completed
Enrollment 87
Est. completion date January 31, 2020
Est. primary completion date January 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 12 Years to 18 Years
Eligibility Inclusion Criteria: - girls between 12 and 18, affiliated to a social security - with behavioral eating disorder characterized by a drastic reduction in intakes resulting in weight loss and a BMI = 17.5 kg / m2. Anorexia can be restrictive pure or associated with bulimia - or, with a BMI projecting = 30 kg / m2 at the age of 18 (IOTF C30) - or, without BMI abnormality, without eating disorders, without serious medical pathology Exclusion Criteria: - for anorexics, uncorrected nutritional deficiency - for the obese, secondary obesity - for all, inability to provide informed consent, pregnancy or breastfeeding, heart disease, high blood pressure, sleep apnea syndrome, dyslipidemia, diabetes, chronic pathology including inflammatory.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
echocardiography
speckle tracking echocardiography evaluation of cardiac variability by recording heart rate as several hours (POLAR watch) bioimpedance blood test for biological assays (metabolomic analysis)

Locations

Country Name City State
France CHU clermont-ferrand Clermont-Ferrand

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary systolic global longitudinal strain echocardiographic parameter of myocardial deformation: index of myocardial systolic function in percent at inclusion
Secondary heart rate variability holter measurement of standard deviation of all intervals between heart beat(SDNN) in ms at inclusion during first night
Secondary body composition fat mass and lean mass in percent at inclusion
Secondary cardiac blood markers blood sampling: N-Terminal-proBNP in ng/L at inclusion
Secondary inflammation blood markers blood sampling: CRP in mg/L at inclusion
Secondary hormonal blood markers blood sampling: oestradiol in pg/ml at inclusion
Secondary blood hemoglobin blood sampling: in g/L at inclusion
Secondary ionogram blood markers blood sampling: blood potassium in mmol/l at inclusion
Secondary heart rhythm and conduction electrocardiogram to determine ECG QT Interval at inclusion
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