NCT04604626: ObeRar

Rare Obesity Cohorts With Food Behavioral Disorders : Better Diagnosis for Better Treatment

Recruiting now Last updated 27 October 2020

What this trial tests

trial in Obesity in 10,000 participants. Currently enrolling.

Timeline

10 June 2020

Primary endpoint
1 July 2022

1 July 2040

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	10,000
Start date	10 June 2020
Primary completion	1 July 2022
Estimated completion	1 July 2040
Sites	1 location across France

Conditions studied

• Obesity — all drugs for Obesity →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

Eligibility, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Hyperphagia and impulsivity: use of self-administered Dykens' and in-house impulsivity questionnaires to characterize eating behaviors in children with severe and early-onset obesity.
   Arnouk L, Chantereau H, Courbage S, Tounian P, et al · · 2024 · cited 11× · PMID 38395939 · DOI 10.1186/s13023-024-03085-1