NCT01298180|CompletedPhase 4
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Sponsor study identifier
Secondary identifiers
OTHER_GRANT · PHRC 2008
interventional
111
1 country
26
Study Start
January 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2013
Actual (reported)Study Completion
May 2013
Actual (reported)The purpose of this study is to estimate the sensibility at the growth hormone in vivo at the children presenting a Prader-Willi syndrome (SPW) in comparison with children presenting a deficit in growth hormone (GHD).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2009
Date type not reportedThis date has not been verified as actual or estimated.
November 6, 2009
Actual (reported)February 17, 2011
Actual (reported)May 2013
Actual (reported)May 2013
Actual (reported)Measure of the circulating rates of IGF-I under treatment.
Before starting treatment: baseline (J0)
Measure of the circulating rates of IGF-I under treatment.
1 month (M1)
Measure of the circulating rates of IGF-I under treatment.
3 month (M3)
Measure of the circulating rates of IGF-I under treatment.
6 month (M6)
Measure of the circulating rates of IGF-I under treatment.
1 year (M12)
Measure of the circulating rate of IGFBP-3, GHBP, ghrelin and apelin.
Before starting treatment (J0)
Measure of physical composition's variation.
Before starting treatment (J0)
Measure of blood sugar level, H.G.P.O., and hyperglycaemia.
Before starting treatment (J0)
Measure of the sensibility at the growth hormone in vitro, on fibroblasts and adipocytes obtained by biopsy.
Before starting treatment (J0)
Measure of the circulating rate of IGFBP-3, GHBP, ghrelin and apelin.
3 months (M3)
Children presenting a Prader-Willi Syndrome
Patient deficient in Growth Hormone
drug : the treatment will be begun in progressive dose by beginning by ¼ of the dose the first week, then ½ of the dose the second week, then 3/4 of the dose the third week and total dose the fourth week.
CHU Amiens Hôpital Nord Service Pédiatrie - Place Victor Pauchet
Amiens, 80054, France
CHU Angers - 4 rue Larrey
Angers, 49000, France
CHG Avignon - 305, rue Raoul Follereau
Avignon, 84902, France
CHU Besançon Hôpital Saint Jacques - 2 Place Saint Jacques
Besançon, 25000, France
CHU Bordeaux Hôpital Pellegrin Service endocrinologie de l'enfant - Place Amélie Raba Léon
Bordeaux, 33076, France
CHU Brest Département de Pédiatrie - 5, ave Foch
Brest, 29609, France
CHU Dijon Service de pédiatrie - 2, Bd Maréchal de lattre de Tassigny
Cadoudal T, Buleon M, Sengenes C, Diene G, Desneulin F, Molinas C, Eddiry S, Conte-Auriol F, Daviaud D, Martin PG, Bouloumie A, Salles JP, Tauber M, Valet P. Impairment of adipose tissue in Prader-Willi syndrome rescued by growth hormone treatment. Int J Obes (Lond). 2014 Sep;38(9):1234-40. doi: 10.1038/ijo.2014.3. Epub 2014 Jan 10.
Eddiry S, Diene G, Molinas C, Salles J, Auriol FC, Gennero I, Bieth E, Skryabin BV, Rozhdestvensky TS, Burnett LC, Leibel RL, Tauber M, Salles JP. SNORD116 and growth hormone therapy impact IGFBP7 in Prader-Willi syndrome. Genet Med. 2021 Sep;23(9):1664-1672. doi: 10.1038/s41436-021-01185-y. Epub 2021 May 26.
Maithé TAUBER, MD
University Hospital, Toulouse
111 participants (actual enrollment reported by the registry).
First Submitted
November 6, 2009
First Posted
February 17, 2011
Study Start
January 2009
Date type not reportedThis date has not been verified as actual or estimated.
IGF1 Generation Test
Patient with Prader-Willi Syndrome who has Biopsy
Patient Control
Patient with Prader-Willi Syndrome taking growth Hormone and who has biopsy
SPW, GHD, SPW-B : blood tests : centralized dosage H.G.P.O : adjusted to children's age.
Biopsy : Cutaneous and fat tissue biopsy.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Dijon, 21000, France
CHU Grenoble Service de pédiatrie - BP 217
Grenoble, 38043, France
CHU La Rochelle Service de Pédiatrie - Rue du Dr Schweitzer
La Rochelle, 17000, France
CHRU Lille Hôpital Jeanne de Flandre service de Pédiatrie
Lille, 59037, France
CHU Limoges Hôpital Mère Enfant Service Pédiatrie - 8, ave du Larrey
Limoges, 87042, France
CHU Lorient Hôpital du Scorff Pôle Femme Mère Enfant - Rue Guiguen
Lorient, 56100, France
CHU Lyon Hôpital Debrousse service Pédiatrie
Lyon, 69322, France
AP-HM Hôptal La Timone Service de Pédiatrie Mutidisciplinaire
Marseille, 13385, France
CHU Montpellier Hôpital Arnaud de Villeneuve - 371 ave du doyen Gaston Giraud
Montpellier, 34000, France
CHU Nantes Hôpital Mère Enfant Service de Pédiatrie
Nantes, 44093, France
CHU Nice Hôpital Archet 2 - 151 route Saint Antoine de Ginestière
Nice, 06202, France
AP-HP Hôpital Necker Enfants Malades Service d'endocrinologie pédiatrique - 149 route de Sèvres
Paris, 75015, France
CHU Poitiers Service de Pédiatrie - Rue de la Miléterie
Poitiers, 86021, France
CHU Reims Service de Pédiatrie - 47, rue Cognacq-Jay
Reims, 51092, France
CHU Rouen Hôpital Nicolle - 1, rue de Germont
Rouen, 76000, France
CHU Saint-Etienne Hôpital Nord Service de Pédiatrie
Saint-Etienne, 42055, France
CHU Strasbourg Hôpital Haute-Pierre - Avenue Molière
Strasbourg, 67200, France
CHU Toulouse Hôpital des Enfants Service d'endocrinologie - 330 ave de Grande Bretagne
Toulouse, 31059, France
CHRU Tours Centre de Pédiatrie Gatien de Clocheville
Tours, 37044, France
Hôpital d'Enfants - Rue Morvan
Vandœuvre-lès-Nancy, 54511, France
Bieth E, Eddiry S, Gaston V, Lorenzini F, Buffet A, Conte Auriol F, Molinas C, Cailley D, Rooryck C, Arveiler B, Cavaille J, Salles JP, Tauber M. Highly restricted deletion of the SNORD116 region is implicated in Prader-Willi Syndrome. Eur J Hum Genet. 2015 Feb;23(2):252-5. doi: 10.1038/ejhg.2014.103. Epub 2014 Jun 11.
Salles J, Eddiry S, Amri S, Galindo M, Lacassagne E, George S, Mialhe X, Lhuillier E, Franchitto N, Jeanneteau F, Gennero I, Salles JP, Tauber M. Differential DNA methylation in iPSC-derived dopaminergic neurons: a step forward on the role of SNORD116 microdeletion in the pathophysiology of addictive behavior in Prader-Willi syndrome. Mol Psychiatry. 2024 Sep;29(9):2742-2752. doi: 10.1038/s41380-024-02542-4. Epub 2024 Apr 2.
Primary Completion
May 2013
Actual (reported)Study Completion
May 2013
Actual (reported)Last Updated
September 24, 2021
Record last verified: 2021-09
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Source: ClinicalTrials.gov.
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