Understanding and improving treatment for rare obesity linked to food behavior disorders

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

This study is trying to find better ways to diagnose and treat hypothalamic obesity in adults and children who struggle with severe obesity and eating behavior issues.

Quick facts

• Study type: Observational
• Enrollment: 10000 (estimated)
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (other)
• Locations: 1 site (La Defense)
• Trial ID: NCT04604626 on ClinicalTrials.gov

What this trial studies

This observational study focuses on hypothalamic obesity (HO), a rare form of obesity caused by dysfunction in the hypothalamus, which regulates energy balance. It aims to better diagnose and manage HO by examining patients with genetic and lesional causes of obesity, including conditions like Prader-Willi syndrome. The study will involve adults and children with severe obesity and eating behavior disorders, assessing their clinical characteristics and needs. The goal is to enhance clinical management strategies that currently rely on behavioral support.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with a BMI greater than 35 or children under 18 with a BMI Z-score above +3, who also exhibit eating behavior disorders.

Not a fit: Patients without severe obesity or those not exhibiting eating behavior disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnosis and management strategies for patients suffering from hypothalamic obesity.

How similar studies have performed: While there is limited research specifically on hypothalamic obesity, studies on genetic obesity syndromes have shown promise in understanding and managing these conditions.

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

Where this trial is running

La Defense

• Pitié-Salpêtrière Hospital, AP-HP -Nutrition department — La Defense, France (RECRUITING)

Study contacts

• Principal investigator: CHRISTINE POITOU-BERNERT, Professor — Assistance Publique - Hôpitaux de Paris
• Study coordinator: CHRISTINE POITOU-BERNERT, Professor

Conditions: Obesity