Is There a Sensibility Increased in the Growth Hormone at Child With Prader-Willi Syndrome?
Information source: University Hospital, Toulouse
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prader-Willi Syndrome; Growth Hormone Deficiency
Intervention: Growth hormone (Genotonorm® or Omnitrope®) (Drug); DEXA, blood tests, H.G.P.O, osseous age. (Procedure); biopsy (Procedure)
Phase: Phase 4
Status: Completed
Sponsored by: University Hospital, Toulouse Official(s) and/or principal investigator(s): Maithé TAUBER, MD, Principal Investigator, Affiliation: University Hospital, Toulouse
Summary
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).
Clinical Details
Official title: Is There a Sensibility Increased in the Growth Hormone at Child With Prader-Willi Syndrome?
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Measure of the circulating rates of IGF-I under treatment.Measure of the circulating rates of IGF-I under treatment. Measure of the circulating rates of IGF-I under treatment. Measure of the circulating rates of IGF-I under treatment. Measure of the circulating rates of IGF-I under treatment.
Secondary outcome: Measure of the circulating rate of IGFBP-3, GHBP, ghrelin and apelin.Measure of physical composition's variation. Measure of blood sugar level, H.G.P.O., and hyperglycaemia. Measure of the sensibility at the growth hormone in vitro, on fibroblasts and adipocytes obtained by biopsy. Measure of the circulating rate of IGFBP-3, GHBP, ghrelin and apelin. Measure of the circulating rate of IGFBP-3, GHBP, ghrelin and apelin. Measure of the circulating rate of IGFBP-3, GHBP, ghrelin and apelin. Measure of physical composition's variation. Measure of physical composition's variation. Measure of physical composition's variation. Measure of blood sugar level, H.G.P.O., and hyperglycaemia. Measure of blood sugar level, H.G.P.O., and hyperglycaemia. Measure of blood sugar level, H.G.P.O., and hyperglycaemia. Measure of the sensibility at the growth hormone in vitro, on fibroblasts and adipocytes obtained by biopsy. Measure of the sensibility at the growth hormone in vitro, on fibroblasts and adipocytes obtained by biopsy. Measure of the sensibility at the growth hormone in vitro, on fibroblasts and adipocytes obtained by biopsy.
Detailed description:
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) by the measure of the circulating rates of IGF-I under treatment.
Eligibility
Minimum age: 1 Year.
Maximum age: 5 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. SPW and SPW-B :
- Female or male child of age > or = 1 year
- Child naïve of treatment by GH and that must begin a treatment with GH
- Child covered by a national insurance scheme or an equivalent
- Signature of the informed consent by one of both holders of the parental
authority
2. GHD :
- Female or male child of age > or = 1 year
- Child paired for the age (+/-on 1 year) and for the sex with regard to the group
SWP
- Child presenting a GH* deficiency defined by :
Growth criteria of size (size) < 2 DS) Criteria of speed of growth (speed of growth <
1 DS over the last year) 2 tests of pharmacological stimulation of GH with peak GH
max < 20 mUI
- Child naïve of treatment by GH and that must begin a treatment with GH
- Child covered by a national insurance scheme or an equivalent
- Signature of the informed consent by one of both holders of the parental
authority * The deficit in GH can be isolated or associated with one or several
other hormonal deficits: deficit in TSH, deficit in ACTH, deficit in LH-FSH,
deficit in prolactin. The child GHD can thus receive other treatments associated
with the growth hormone.
3. T : controls
- Female or male child of age > or = 1 year
- Child paired for the age (+/-on 1 year) and for the sex with regard to the group
SWP
- Child hospitalized at the hospital of the children of the University Hospital of
Toulouse for a programmed surgical operation
- Child covered by a national insurance scheme or an equivalent
- Signature of the informed consent by one of both holders of the parental
authority
4. SPW-GH-B :
- Female or male child of age > or = 1 year
- Child hospitalized for a programmed surgical operation
- Child covered by a national insurance scheme or an equivalent
- Child treated with GH for at least 3 month
- Signature of the informed consent by one of both holders of the parental
authority
Exclusion Criteria:
1. SPW and GHD
- Child presenting a contraindication to the taking of growth hormone :
- Growth cartilage welded
- Tumoral pathology in process of evolution
- Corticosteroid therapy (not substitute)
- Allergy known about solvent
- Badly balanced diabetes
- Child presenting a hypersensitivity to the active principle or to one of the
excipients of Genotonorm ® or Omnitrope ®
- Child presenting a severe obesity (defined by a report weight / size > 200 %)
- Child presenting clinical signs ENT (snores associated with a hypertrophy of the
adenoids vegetations and\or the tonsils)
- Child presenting clinical signs evoking a respiratory illness of the sleep
(night-respiratory snores, respiratory breaks during the sleep)
2. SPW-B:
- Child presenting a hypersensitivity to the local anaesthetic with amide
connecion
- Child presenting a hypersensitivity to the components of the bandage Emlapatch®
- Child presenting a hypersensitivity to one of the components of the lidocaïne
aguettant without conservative®
- Child presenting a porphyria
- Child presenting a congenital methemoglobinemia
- Child presenting a contraindication to Meopa : patients requiring a ventilation
in pure oxygen, intracranial High blood pressure, Any change of the state of
consciousness, preventing the cooperation of the patient, Pneumothorax, Bubbles
of emphysema, Gaseous embolism, Accident of dive, abdominal gaseous Distension,
Patient having received recently an ophthalmic gas (SF6, C3F8, C2F6) used in the
eye surgery as long as persists a bubble of gas inside the eye and at least
during a period of 3 months. Grave postoperative complications can arise in
touch with the increase of the pressure intraocular, facial Traumatism
interesting the region of application of the mask
3. T : controls
- Chronicle pathology in which an abnormality of growth would be involved
- Other hormonal abnormalities
- Children receiving a treatment on the long range, corticosteroid therapy in
particular, being able to interfere with the sensibility to GH or to the insulin
- Holder of the parental authority under supervision, guardianship or under
protection of justice
- Participation in another study simultaneously at this one
Locations and Contacts
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, Besancon 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, 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, Vandoeuvre Les Nancy 54511, France
Additional Information
Related publications: Cadoudal T, Buléon M, Sengenès C, Diene G, Desneulin F, Molinas C, Eddiry S, Conte-Auriol F, Daviaud D, Martin PG, Bouloumié 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.
Starting date: January 2009
Last updated: May 26, 2015
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