NCT04604626Recruiting
Rare Obesity Cohorts With Food Behavioral Disorders : Better Diagnosis for Better Treatment
Source: ClinicalTrials.gov · Last updated 27 Oct 2020 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 10000 (estimated)
- First submitted
- 7 Apr 2020
- Start date
- 10 Jun 2020
- Primary completion date
- 1 Jul 2022
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Obesity
- NCT number
- NCT04604626
What you commit to
- Study type: Observational
- Planned participants: 10000
- From 10 Jun 2020 to the primary completion date, 1 Jul 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Refusing to participate in the study
- Not mastering the french language
- Safety measure
Who the study is looking for
- Population 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
- 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)
- 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
- Adult or child with obesity and / or eating disorder due to hypothalamic lesion (craniopharyngioma for example)
- 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).
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pitié-Salpêtrière Hospital, AP-HP -Nutrition department Coordinator of this site? Confirm its status | La Defense | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.