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

NCT04604626 | Recruiting

• 2 other identifiers: APHP2001812019-A03201-56
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• This criterion is the age of obesity beginning

  A BMI curve is performed using the aggregation of multiple measurements (eg weight in kg and height in meters) during childhood. Retrospective data on height and weight collected every year form birth to the age BMI= weight/height², Obesity is defined for a BMI above the IOTF curve

  For adults, at inclusion. For children at inclusion and every three years (from date of inclusion until the date of first documented BMI>IOTF 30 kg/m²) (e.g from date of inclusion until the end of follow up, so 20 years)

Secondary Outcomes (36)

• Maximum weight in kg

  at inclusion and during follow-up evaluation visit every 5 years (e.g from date of inclusion until the end of follow up, so 20 years)

• Maximum height in m

  at inclusion and during follow-up evaluation visit every 5 years (e.g from date of inclusion until the end of follow up, so 20 years)

• Adult: number of calories/24h with distribution of macronutrients

  at inclusion and during follow-up evaluation visit every 5 years (e.g from date of inclusion until the end of follow up, so 20 years)

• Adult: binge eating behavior

  at inclusion and during follow-up evaluation visit every 5 years (e.g from date of inclusion until the end of follow up, so 20 years)

• Adult: hyperphagia

  at inclusion and during follow-up evaluation visit every 5 years (e.g from date of inclusion until the end of follow up, so 20 years)

Study Arms (2)

Population 1

Adults and children with severe obesity ie (BMI\> 35 kg / m² for adults and Z BMI score\> 3DS for age and sex for children) and / or eating disorders with genetic diagnosis as part of care.

Population 2

Adults and children with obesity and / or eating disorders hypothalamic lesion (craniopharyngioma example).

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Population 1: Adults and children with severe obesity ie (BMI\> 35 kg / m² for adults and Z BMI score\> 3DS for age and sex for children) and / or eating disorders with genetic diagnosis as part of care This population will be divided into 5 groups according to the genetic diagnosis made * Prader willi syndrome (SPW) * syndromic obesity except prader willi (OS) * obesity by homozygous mutation of the melanocortin pathway (HomMel) * obesity by heterozygous mutation of the melanocortin pathway (HetMel) * controls without genetic abnormality found in view of the final results of the genetic diagnosis(CON) Population 2: Adults and children with obesity and / or eating disorders hypothalamic lesion (craniopharyngioma example)

You may qualify if:

• 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).

You may not qualify if:

• Refusing to participate in the study
• Not mastering the french language
• Safety measure

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Pitié-Salpêtrière Hospital, AP-HP -Nutrition department

La Defense, 75013, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

serum, DNA, urine, stool, and adipose tissue

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• CHRISTINE POITOU-BERNERT, Professor

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

CHRISTINE POITOU-BERNERT, Professor

CONTACT

(33)1.42.17.57.71; christine.poitou-bernert@aphp.fr

BEATRICE DUBERN, Professor

CONTACT

33 (1) 44 73 64 46; beatrice.dubern@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 20 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: October 27, 2020
• Study Start: June 10, 2020
• Primary Completion: July 1, 2022
• Study Completion (Estimated): July 1, 2040
• Last Updated: October 27, 2020

Record last verified: 2020-03

Locations

FR (1)