Anorexia NervosaNCT05071157
Study of the Effects of Adolescent Weight Disorders (Obesity, Anorexia Nervosa) on Heart Function
An observational study of Anorexia Nervosa and Obesity, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa, Obesity
- What is being tested?
- echocardiography
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 87 participants
- Where
- 1 siteFrance
- Study dates
- 6 Mar 2019to 31 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: girls between 12 and 18 with or without weight disorders
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Anorexia Nervosa, Obesity
- Being tested
- echocardiography
- Keywords
- cardiac function, adolescent, obesity, speckle tracking echocardiography, anorexia nervosa, metabolomic
- Medical subject headings
- Anorexia Nervosa, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
echocardiographyBehavioural
- speckle tracking echocardiography
- evaluation of cardiac variability by recording heart rate as several hours (POLAR watch)
- bioimpedance
- blood test for biological assays (metabolomic analysis)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: echocardiography | |
| obesity | girls between 12 and 18 years old with a BMI projecting ≥ 30 kg / m2 at the age of 18 (IOTF C30). Receives: Behavioral: echocardiography | |
| normal weight | girls between 12 and 18 years old without BMI abnormality, without eating disorders, without serious medical pathology Receives: Behavioral: echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
systolic global longitudinal strain
echocardiographic parameter of myocardial deformation: index of myocardial systolic function in percent
Measured: at inclusion
Secondary outcomes (8)
heart rate variability
holter measurement of standard deviation of all intervals between heart beat(SDNN) in ms
Measured: at inclusion during first night
body composition
fat mass and lean mass in percent
Measured: at inclusion
cardiac blood markers
blood sampling: N-Terminal-proBNP in ng/L
Measured: at inclusion
inflammation blood markers
blood sampling: CRP in mg/L
Measured: at inclusion
hormonal blood markers
blood sampling: oestradiol in pg/ml
Measured: at inclusion
blood hemoglobin
blood sampling: in g/L
Measured: at inclusion
ionogram blood markers
blood sampling: blood potassium in mmol/l
Measured: at inclusion
heart rhythm and conduction
electrocardiogram to determine ECG QT Interval
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start6 Mar 2019
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Justine Paysal, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05071157
- Sponsor's protocol ID
- RBHP 2018 PAYSAL
- Other IDs
- 2018-A01907-48
- Status last verified
- Jan 2023
- First submitted
- 14 Sep 2021
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effects of Adolescent Weight Disorders (Obesity, Anorexia Nervosa) on Heart Function
- ClinicalTrials.gov ID
- NCT05071157
- Acronym / sponsor ID
- RBHP 2018 PAYSAL
- Conditions
- Anorexia Nervosa, Obesity
- Keywords
- cardiac function, adolescent, obesity, speckle tracking echocardiography, anorexia nervosa, metabolomic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 6 Mar 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 8 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| anorexia nervosa | – | Behavioral: echocardiographygirls 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 |
| obesity | – | Behavioral: echocardiographygirls between 12 and 18 years old with a BMI projecting ≥ 30 kg / m2 at the age of 18 (IOTF C30). |
| normal weight | – | Behavioral: echocardiographygirls between 12 and 18 years old without BMI abnormality, without eating disorders, without serious medical pathology |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- girls between 12 and 18 with or without weight disorders
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Behavioural | anorexia nervosa, normal weight, obesity |
Primary outcome
systolic global longitudinal strain
Time frame: at inclusion
echocardiographic parameter of myocardial deformation: index of myocardial systolic function in percent
8 secondary outcomes
heart rate variability
Time frame: at inclusion during first night
body composition
Time frame: at inclusion
cardiac blood markers
Time frame: at inclusion
inflammation blood markers
Time frame: at inclusion
hormonal blood markers
Time frame: at inclusion
blood hemoglobin
Time frame: at inclusion
ionogram blood markers
Time frame: at inclusion
heart rhythm and conduction
Time frame: at inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justine Paysal principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorexia Nervosa and Obesity, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
systolic global longitudinal strain (time frame: at inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.