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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

Page last updated: August 23, 2015

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