Ghrelin in Patients With a Rare Disease Associated With Intellectual Disability, and Hyperphagia, and/or Overweight, and/or Obesity
HOGRID
Circulating Levels of Ghrelin in Patients With a Rare Disease Associated With Intellectual Disability, and Hyperphagia, and / or Overweight, and / or Obesity
1 other identifier
observational
300
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2021
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2021
CompletedFirst Posted
Study publicly available on registry
February 24, 2021
CompletedStudy Start
First participant enrolled
June 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2023
CompletedAugust 24, 2023
August 1, 2023
2.5 years
February 16, 2021
August 22, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Levels of ghrelin in blood sample
dosage of ghrelin (pmol /l)
Day 1
Secondary Outcomes (7)
Overeating
Day 1
Overeating
Day 1
Behavioral disorder description
Day 1
Behavioral disorder description
Day 1
Social vulnerability of parents and / or legal guardians
Day 1
- +2 more secondary outcomes
Interventions
realization of plasma samples to evaluate of levels of ghrelin and collection of plasma and cells
Eligibility Criteria
patients infants and adults presenting a rare disease with overweight and hyperphagic behavior
You may qualify if:
- 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.
You may not qualify if:
- Administrative problems: impossibility of giving parents or legal guardians informed information ; no coverage by a Social Security scheme.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
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, France
Biospecimen
collection de plasma et cellules sanguines
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maithé TAUBER, MD
University Hospital, Toulouse
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2021
First Posted
February 24, 2021
Study Start
June 10, 2021
Primary Completion
December 15, 2023
Study Completion
December 15, 2023
Last Updated
August 24, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share