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Completed

NCT Number: NCT05071157

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.

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Key information

Age range

12 year–18 year

Sex eligibility

Female

Study type

Observational

Primary location

CHU clermont-ferrand

Clermont-Ferrand, France

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

echocardiography

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)

Primary outcomes

  1. systolic global longitudinal strain

    Time frame: at inclusion

    echocardiographic parameter of myocardial deformation: index of myocardial systolic function in percent

Secondary outcomes

  1. heart rate variability

    Time frame: at inclusion during first night

    holter measurement of standard deviation of all intervals between heart beat(SDNN) in ms

  2. body composition

    Time frame: at inclusion

    fat mass and lean mass in percent

  3. cardiac blood markers

    Time frame: at inclusion

    blood sampling: N-Terminal-proBNP in ng/L

  4. inflammation blood markers

    Time frame: at inclusion

    blood sampling: CRP in mg/L

  5. hormonal blood markers

    Time frame: at inclusion

    blood sampling: oestradiol in pg/ml

  6. blood hemoglobin

    Time frame: at inclusion

    blood sampling: in g/L

  7. ionogram blood markers

    Time frame: at inclusion

    blood sampling: blood potassium in mmol/l

  8. heart rhythm and conduction

    Time frame: at inclusion

    electrocardiogram to determine ECG QT Interval

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 8, 2021
Registry last updated
Jan 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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