Clinical trial NCT05071157: Study of the Effects of Adolescent Weight Disorders (Obesity, Anorexia Nervosa) on Heart Function
Official title: Study of the Effects of Adolescent Weight Disorders (Obesity, Anorexia Nervosa) on Heart Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anorexia Nervosa
Obesity
Keywords: cardiac function
adolescent
obesity
speckle tracking echocardiography
anorexia nervosa
metabolomic
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2021-10-08
Enrollment: 87
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: girls between 12 and 18 with or without weight disorders

Brief 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.

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: systolic global longitudinal strain
timeFrame: at inclusion
Secondary outcomes:
measure: heart rate variability
timeFrame: at inclusion during first night
measure: body composition
timeFrame: at inclusion
measure: cardiac blood markers
timeFrame: at inclusion
measure: inflammation blood markers
timeFrame: at inclusion
measure: hormonal blood markers
timeFrame: at inclusion
measure: blood hemoglobin
timeFrame: at inclusion
measure: ionogram blood markers
timeFrame: at inclusion
measure: heart rhythm and conduction
timeFrame: at inclusion
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU clermont-ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Justine Paysal
role: PRINCIPAL_INVESTIGATOR
References: