Study of the Effects of Adolescent Weight Disorders (Obesity, Anorexia Nervosa) on Heart Function

Sponsor

University Hospital, Clermont-Ferrand (Other)

Overall Status

Recruiting

CT.gov ID

NCT05071157

Collaborator

(none)

Enrollment

Location

31.9

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anorexia Nervosa Obesity	Behavioral: echocardiography

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

Study Design

Study Type:

Observational

Anticipated Enrollment :

90 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Study of the Effects of Adolescent Weight Disorders (Obesity, Anorexia Nervosa) on Heart Function

Actual Study Start Date :

Mar 6, 2019

Anticipated Primary Completion Date :

Nov 1, 2021

Anticipated Study Completion Date :

Nov 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
anorexia nervosa girls between 12 and 18 years old 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	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)
obesity girls between 12 and 18 years old with a BMI projecting ≥ 30 kg / m2 at the age of 18 (IOTF C30).	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)
normal weight girls between 12 and 18 years old without BMI abnormality, without eating disorders, without serious medical pathology	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)

Arm

Intervention/Treatment

anorexia nervosa

girls between 12 and 18 years old 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

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)

obesity

girls between 12 and 18 years old with a BMI projecting ≥ 30 kg / m2 at the age of 18 (IOTF C30).

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)

normal weight

girls between 12 and 18 years old without BMI abnormality, without eating disorders, without serious medical pathology

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)

Outcome Measures

Primary Outcome Measures

systolic global longitudinal strain [at inclusion]
echocardiographic parameter of myocardial deformation: index of myocardial systolic function in percent

Secondary Outcome Measures

heart rate variability [at inclusion during first night]
holter measurement of standard deviation of all intervals between heart beat(SDNN) in ms
body composition [at inclusion]
fat mass and lean mass in percent
cardiac blood markers [at inclusion]
blood sampling: N-Terminal-proBNP in ng/L
inflammation blood markers [at inclusion]
blood sampling: CRP in mg/L
hormonal blood markers [at inclusion]
blood sampling: oestradiol in pg/ml
blood hemoglobin [at inclusion]
blood sampling: in g/L
ionogram blood markers [at inclusion]
blood sampling: blood potassium in mmol/l
heart rhythm and conduction [at inclusion]
electrocardiogram to determine ECG QT Interval

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 18 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.