Epilepsy Clinical Trial
— HOGRIDOfficial title:
Circulating Levels of Ghrelin in Patients With a Rare Disease Associated With Intellectual Disability, and Hyperphagia, and / or Overweight, and / or Obesity
A significantly higher proportion of patients with rare diseases (RD) with intellectual disability (ID), present hyperphagia, overweight or obesity, compared to the general population. Prader-Willi syndrome is the only genetic obesity identified to date associated with hyperghrelinemia, while ghrelin levels are lower than in controls in other situations of obesity. The aim of the study is to find out whether the levels of ghrelin, which are abnormally high in PWS throughout life, are also high in these RD when people have hyperphagia and/or overweight.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | December 15, 2023 |
Est. primary completion date | December 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 50 Years |
Eligibility | Inclusion Criteria: - Patients with one of the following rare diseases associated with : Angelman syndrome, Smith-Magenis syndrome, X Fragile syndrome, rare diseases of the cerebellum, rare epilepsies, PW-like syndromes or other rare diseases with eating disorders - Patients aged minimum 3 years and maximum 50 years. - Patients with overweight (or obesity) and/or hyperphagic behavior. Exclusion Criteria: - Administrative problems: impossibility of giving parents or legal guardians informed information ; no coverage by a Social Security scheme. |
Country | Name | City | State |
---|---|---|---|
France | Centre N°1 : 40 Centre de Référence PRADORT Pr Tauber - Toulouse Centre N°2 : 22 Centre de Référence PRADORT Pr Poitou Bernert - Paris La Pitié Salpetrière Centre N°3 : 15 Centre de Référence DI de causes rares Dr Heron - Paris La Pitié Salpêtrière Centr | Paris | |
France | Tauber | Toulouse |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Toulouse |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Levels of ghrelin in blood sample | dosage of ghrelin (pmol /l) | Day 1 | |
Secondary | Overeating | Dykens overeating questionnaire | Day 1 | |
Secondary | Overeating | eating behavior assessment scale | Day 1 | |
Secondary | Behavioral disorder description | CBCL questionnaire for patients under 18 years old | Day 1 | |
Secondary | Behavioral disorder description | Developmental Behavior Checklist-Adult questionnaire for patients over 18 years old | Day 1 | |
Secondary | Social vulnerability of parents and / or legal guardians | EPICES questionnaire (Assessment of Precariousness and Health Inequalities for the Health Examination Centers). | Day 1 | |
Secondary | Family quality of life (for patients under 18) | Parental-Developmental Disabilities Quality of Life questionnaire | Day1 | |
Secondary | Burden of parents and / or legal guardians | ZBI questionnaire (Zarit Burden Interview). | Day 1 |
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