An interventional study of blood samples in Prader-Willi Syndrome, sponsored by University Hospital, Toulouse. Completed at 6 sites in 6 countries. Open to participants aged Up to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-08.
Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Basic science
The present project aims to determine the underlying mechanisms for the switch from failure to thrive to excessive weight gain and hyperphagia with impaired satiety in PWS. The primary objective is to describe the evolution of circulating hormones involved in feeding and appetite regulation during the 4 first years of life. The secondary objective is to make this blood bank available for other research projects and particularly the investigation of hormones involved in hypogonadism.
Over the last ten years, the age at diagnosis in PWS has fallen significantly and the majority of cases is now diagnosed during the 1st trimester of life giving the possibility to collect precise clinical data and serum samples at early stages. The investigators of the project are involved in the care of patients with PWS and have a devoted clinic and an organized network in their country through clinical networks or patient associations.
The investigators propose to perform a prospective multicentric study, both longitudinal (duration 30 months) and cross-sectional with implementation of a blood bank in link with a multicenter database including clinical data on birth, auxology, endocrine functions and feeding behaviour. The cohort will include 200 infants from 3 to 48 months with PWS and 200 controls matched on age recruited in the 6 participating countries. The investigators make the assumption that 3 blood sampling will be necessary during the first year and 6 monthly sampling thereafter. For measuring hormones and neuropeptides (ghrelin, insulin, leptin, pancreatic polypeptide, oxytocin, cortisol, melatonin, orexin A, GLP-1 and PYY) involved in feeding and appetite regulation the investigators will use primarily multiplex microplates technics requiring 50-200µl of sample. Intragroup and intergroup comparisons will be performed in order to describe the evolution of each hormone with time and to compare data obtained in the PWS group with those obtained in the control group.
138 studies on the registry are indexed under Prader-Willi Syndrome; 24 are open to participants now.
This study's enrollment of 215 is above the median of 30 across 96 interventional studies indexed under Prader-Willi Syndrome.
Browse Prader-Willi Syndrome studies →University Hospital, Toulouse is the lead sponsor of 794 studies on the registry; 214 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria (PWS infants cohort)
Exclusion Criteria (PWS infants cohort)
Inclusion Criteria (control group)
Exclusion Criteria (control group)
Blood samples for the bank in link with a multicenter database including clinical data on birth, auxology, endocrine functions and feeding behaviour
Other: blood samples
Blood samples for the bank in children hospitalized for a planned surgery for malformation, orthopaedic or visceral surgery
Other: blood samples
blood samples for the bank
Levels of hormones and neuropeptides
Measure of hormones and neuropeptides (ghrelin, insulin, leptin, pancreatic polypeptide, oxytocin, melatonin, orexins) involved in feeding and appetite regulation
Time frame: 42 months
Correlation between hormones and neuropeptides levels
study the correlation between ghrelin, insulin, leptin, pancreatic polypeptide, oxytocin, melatonin, orexins
Time frame: 42 months
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Toulouse