NCT05071157

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 6, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

October 8, 2021

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

11 months

First QC Date

September 14, 2021

Last Update Submit

January 17, 2023

Conditions

Anorexia NervosaObesity

Keywords

cardiac functionadolescentobesityspeckle tracking echocardiographyanorexia nervosametabolomic

Outcome Measures

Primary Outcomes (1)

  • systolic global longitudinal strain

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

    at inclusion

Secondary Outcomes (8)

  • heart rate variability

    at inclusion during first night

  • body composition

    at inclusion

  • cardiac blood markers

    at inclusion

  • inflammation blood markers

    at inclusion

  • hormonal blood markers

    at inclusion

  • +3 more secondary outcomes

Study Arms (3)

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

obesity

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

Behavioral: echocardiography

normal weight

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

Behavioral: echocardiography

Interventions

echocardiographyBEHAVIORAL

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

anorexia nervosanormal weightobesity

Eligibility Criteria

Age12 Years - 18 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

girls between 12 and 18 with or without weight disorders

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU clermont-ferrand

Clermont-Ferrand, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood sample for inflammatory factors (CRP, sedimentary rate, metabolomic)

MeSH Terms

Conditions

Anorexia NervosaObesity

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental DisordersOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Justine Paysal

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2021

First Posted

October 8, 2021

Study Start

March 6, 2019

Primary Completion

January 31, 2020

Study Completion

January 31, 2020

Last Updated

January 18, 2023

Record last verified: 2023-01

Locations

FR(1)