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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Anorexia Nervosa
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 87

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France
    • CHU Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

girls between 12 and 18 with or without weight disorders

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
systolic global longitudinal strain	echocardiographic parameter of myocardial deformation: index of myocardial systolic function in percent	at inclusion

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Justine Paysal, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2019
• Primary Completion (Actual): January 31, 2020
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: September 14, 2021
• First Submitted That Met QC Criteria: September 27, 2021
• First Posted (Actual): October 8, 2021

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 17, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: obesity; adolescent; anorexia nervosa; metabolomic; cardiac function; speckle tracking echocardiography
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Anorexia; Anorexia Nervosa; Obesity
• Other Study ID Numbers: RBHP 2018 PAYSAL; 2018-A01907-48 (Other Identifier: 2018-A01907-48)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No