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

NCT ID: NCT05071157

Last Updated: 2023-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

87 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-06

Study Completion Date

2020-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anorexia Nervosa Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

echocardiography

Intervention Type BEHAVIORAL

* 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).

echocardiography

Intervention Type BEHAVIORAL

* 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

echocardiography

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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)

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Justine Paysal

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU clermont-ferrand

Clermont-Ferrand, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2018-A01907-48

Identifier Type: OTHER

Identifier Source: secondary_id

RBHP 2018 PAYSAL

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Echocardiography in Nursing Home
NCT06445231 RECRUITING NA