NCT04604626 Rare Obesity Cohorts With Food Behavioral Disorders : Better Diagnosis for Better Treatment
| NCT ID | NCT04604626 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Obesity |
| Study Type | OBSERVATIONAL |
| Enrollment | 10,000 participants |
| Start Date | 2020-06-10 |
| Primary Completion | 2022-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10,000 participants in total. It began in 2020-06-10 with a primary completion date of 2022-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Hypothalamic obesity (HO) is defined as obesity secondary to functional or anatomical alterations of the hypothalamus, the central organ of energy homeostasis. The causes of HO are related either to hypothalamic lesions (eg craniopharyngioma) either to genetic diseases (syndromic obesity such as Prader-Willi syndrome or monogenic non syndromic obesity such as variants on leptin/melanocortin pathway). HO, which accounts for about 5 to 10% of obesity, groups complex disorders characterized by severe obesity associated with eating disorders, cognitive and behavioral disorders, endocrine and metabolic alterations and sometimes a visual deficit, with a major impact on quality of life, morbidity and mortality. There is currently no specific treatment of HO. Clinical management is essentially behavioral, based on daily support of eating behavior and physical activities. HO is characterized by an intense and almost permanent hunger; a satiety disorder and an obsessive interest in food. The education regarding food intake behavior of the caregivers and relateds is critical with advices concerning the control of the access to food and the setting up of a precise food frame on the quantities, with low energetic density, and schedules. HO are complex medical situations, often refractory to current lifestyle therapies. However innovative therapies with molecules targeting the hypothalamus are emerging. The investigator's main hypothesis is that HO have alterations in eating behavior that can be improved by innovative treatments such as, for example, molecule targeting the melanocortin pathway. The response to therapy could depend on hypothalamic origin and especially on the genotype. ObeRar cohort aims to i) improve early diagnosis of HO and ii) characterize the natural history of obesity and eating disorders, the associated phenotypes and "lifestyle" profiles (physical activity, sleep, nutrition) and cardio-metabolic and neuropsychological parameters. Defining profiles will help personalize individual care management and target patients who can participate in clinical trials with innovative therapeutics. ObeRar-cohort will thus improve the early diagnosis, prognosis, medical management and innovative therapies of these particularly severe forms of rare obesities.
Eligibility Criteria
Inclusion Criteria: * Population 1: 1. Adults ≥ 18 years old with BMI\> 35 kg / m² or children \<18 years old with BMI Zscore\> + 3DS for age and sex and / or eating behavior disorders consulting in one of the participating centers 2. Patient benefiting from a genetic diagnosis as part of his usual care according to criteria justifying a genetic analysis such as: obesity with early onset (\<12 years) or very severe BMI\> 50 kg / m² and / or presence of eating disorders, endocrine abnormalities or other symptoms suggestive of a genetic anomaly (such as: intellectual disability, retinopathy of pigmentation or other) 3. Adult patient or holders of parental authority (for children) having received the information and having signed a free, informed and written consent (or for adult patients under legal protection measure or unable to consent, information and obtaining the consent of the legal representative, the support person, or the relative / close relative). * Population 2 1. Adult or child with obesity and / or eating disorder due to hypothalamic lesion (craniopharyngioma for example) 2. Adult patient or holders of parental authority (for children) having received the information and having signed a free, informed and written consent (or for adult patients under legal protection measure or unable to consent, information and obtaining the consent of the legal representative, the support person, the relative / relative). Exclusion Criteria: 1. Refusing to participate in the study 2. Not mastering the french language 3. Safety measure
Contact & Investigator
CHRISTINE POITOU-BERNERT, Professor
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT04604626 clinical trial?
This trial is open to participants of all sexes, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04604626 currently recruiting?
Yes, NCT04604626 is actively recruiting participants. Contact the research team at christine.poitou-bernert@aphp.fr for enrollment information.
Where is the NCT04604626 trial being conducted?
This trial is being conducted at La Defense, France.
Who is sponsoring the NCT04604626 clinical trial?
NCT04604626 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is CHRISTINE POITOU-BERNERT, Professor at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 10,000 participants.
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