Is There a Sensibility Increased in the Growth Hormone at Child With Prader-Willi Syndrome?
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Prader-Willi Syndrome Growth Hormone Deficiency |
Drug: Growth hormone (Genotonorm® or Omnitrope®) Procedure: DEXA, blood tests, H.G.P.O, osseous age. Procedure: biopsy |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Is There a Sensibility Increased in the Growth Hormone at Child With Prader-Willi Syndrome? |
- Measure of the circulating rates of IGF-I under treatment. [ Time Frame: Before starting treatment: baseline (J0) ] [ Designated as safety issue: No ]
- Measure of the circulating rates of IGF-I under treatment. [ Time Frame: 1 month (M1) ] [ Designated as safety issue: No ]
- Measure of the circulating rates of IGF-I under treatment. [ Time Frame: 3 month (M3) ] [ Designated as safety issue: No ]
- Measure of the circulating rates of IGF-I under treatment. [ Time Frame: 6 month (M6) ] [ Designated as safety issue: No ]
- Measure of the circulating rates of IGF-I under treatment. [ Time Frame: 1 year (M12) ] [ Designated as safety issue: No ]
- Measure of the circulating rate of IGFBP-3, GHBP, ghrelin and apelin. [ Time Frame: Before starting treatment (J0) ] [ Designated as safety issue: No ]
- Measure of physical composition's variation. [ Time Frame: Before starting treatment (J0) ] [ Designated as safety issue: No ]
- Measure of blood sugar level, H.G.P.O., and hyperglycaemia. [ Time Frame: Before starting treatment (J0) ] [ Designated as safety issue: No ]
- Measure of the sensibility at the growth hormone in vitro, on fibroblasts and adipocytes obtained by biopsy. [ Time Frame: Before starting treatment (J0) ] [ Designated as safety issue: No ]
- Measure of the circulating rate of IGFBP-3, GHBP, ghrelin and apelin. [ Time Frame: 3 months (M3) ] [ Designated as safety issue: No ]
- Measure of the circulating rate of IGFBP-3, GHBP, ghrelin and apelin. [ Time Frame: 6 months (M6) ] [ Designated as safety issue: No ]
- Measure of the circulating rate of IGFBP-3, GHBP, ghrelin and apelin. [ Time Frame: 1 year (M12) ] [ Designated as safety issue: No ]
- Measure of physical composition's variation. [ Time Frame: 3 months (M3) ] [ Designated as safety issue: No ]
- Measure of physical composition's variation. [ Time Frame: 6 months (M6) ] [ Designated as safety issue: No ]
- Measure of physical composition's variation. [ Time Frame: 1 year (M12) ] [ Designated as safety issue: No ]
- Measure of blood sugar level, H.G.P.O., and hyperglycaemia. [ Time Frame: 3 months (M3) ] [ Designated as safety issue: No ]
- Measure of blood sugar level, H.G.P.O., and hyperglycaemia. [ Time Frame: 6 months (M6) ] [ Designated as safety issue: No ]
- Measure of blood sugar level, H.G.P.O., and hyperglycaemia. [ Time Frame: 1 year (M12) ] [ Designated as safety issue: No ]
- Measure of the sensibility at the growth hormone in vitro, on fibroblasts and adipocytes obtained by biopsy. [ Time Frame: 3 months (M3) ] [ Designated as safety issue: No ]
- Measure of the sensibility at the growth hormone in vitro, on fibroblasts and adipocytes obtained by biopsy. [ Time Frame: 6 months (M6) ] [ Designated as safety issue: No ]
- Measure of the sensibility at the growth hormone in vitro, on fibroblasts and adipocytes obtained by biopsy. [ Time Frame: 1 year (M12) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 170 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: SPW
Children presenting a Prader-Willi Syndrome
|
Drug: Growth hormone (Genotonorm® or Omnitrope®)
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.
Procedure: DEXA, blood tests, H.G.P.O, osseous age.
SPW, GHD, SPW-B : blood tests : centralized dosage H.G.P.O : adjusted to children's age. |
|
Experimental: GHD
Patient deficient in Growth Hormone
|
Drug: Growth hormone (Genotonorm® or Omnitrope®)
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.
Procedure: DEXA, blood tests, H.G.P.O, osseous age.
SPW, GHD, SPW-B : blood tests : centralized dosage H.G.P.O : adjusted to children's age. |
|
Experimental: SPW-B
Patient with Prader-Willi Syndrome who has Biopsy
|
Drug: Growth hormone (Genotonorm® or Omnitrope®)
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.
Procedure: DEXA, blood tests, H.G.P.O, osseous age.
SPW, GHD, SPW-B : blood tests : centralized dosage H.G.P.O : adjusted to children's age. Biopsy : Cutaneous and fat tissue biopsy.
|
|
Experimental: T
Patient Control
|
Procedure: biopsy
Biopsy : Cutaneous and fat tissue biopsy.
|
|
Experimental: SPW-GH-B
Patient with Prader-Willi Syndrome taking growth Hormone and who has biopsy
|
Procedure: biopsy
Biopsy : Cutaneous and fat tissue 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| Ages Eligible for Study: | 1 Year to 5 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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
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.
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
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:
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)
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
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
Contacts and Locations| Contact: Maïthé TAUBER, Professor | 05 34 55 85 51 ext 33 | tauber.m@chu-toulouse.fr |
| Contact: Flavie DESNEULIN, CRA | 05 61 77 13 82 | desnaulin.f@chu-toulouse.fr |
| France | |
| CHU Amiens Hôpital Nord Service Pédiatrie - Place Victor Pauchet | Recruiting |
| Amiens, France, 80054 | |
| Contact: Hélène BONY-TRIFUNOVIC, MD 03 22 66 82 66 ext 33 bony.helene@chu-amiens.fr | |
| Principal Investigator: Hélène BONY-TRIFUNOVIC, MD | |
| CHU Angers - 4 rue Larrey | Recruiting |
| Angers, France, 49000 | |
| Contact: Régis COUTANT, MD 02 41 35 56 55 ext 33 recoutant@chu-angers.fr | |
| Principal Investigator: Régis COUTANT, MD | |
| CHG Avignon - 305, rue Raoul Follereau | Recruiting |
| Avignon, France, 84902 | |
| Contact: Abdallah TIZEGGAGHINE, MD 04 32 75 36 69 ext 33 atizeggaghine@ch-avignon.fr | |
| Principal Investigator: Abdallah TIZEGGAGHINE, MD | |
| CHU Besançon Hôpital Saint Jacques - 2 Place Saint Jacques | Recruiting |
| Besancon, France, 25000 | |
| Contact: Anne-Marie BERTRAND, MD 03 81 21 81 34 marie@wanadoo.fr | |
| Principal Investigator: Anne-Marie BERTRAND, MD | |
| CHU Bordeaux Hôpital Pellegrin Service endocrinologie de l'enfant - Place Amélie Raba Léon | Recruiting |
| Bordeaux, France, 33076 | |
| Contact: Pascal BARAT, MD 05 56 79 87 25 ext 33 pascal.barat@chu-bordeaux.fr | |
| Principal Investigator: Pascal BARAT, MD | |
| CHU Brest Département de Pédiatrie - 5, ave Foch | Recruiting |
| Brest, France, 29609 | |
| Contact: Chantal METZ, MD 02 98 22 33 81 ext 33 chantal.metz@chu-brest.fr | |
| Principal Investigator: Chantal METZ, MD | |
| CHU Dijon Service de pédiatrie - 2, Bd Maréchal de lattre de Tassigny | Not yet recruiting |
| Dijon, France, 21000 | |
| Contact: Frédéric HUET, MD 03 80 29 34 15 ext 33 frederic.huet@chu-dijon.fr | |
| Principal Investigator: Fédéric HUET, MD | |
| CHU Grenoble Service de pédiatrie - BP 217 | Recruiting |
| Grenoble, France, 38043 | |
| Contact: Clémentine DUPUIS, MD 04 76 76 54 18 ext 33 CDupuis@chu-grenoble.fr | |
| Principal Investigator: Clémentine DUPUIS, MD | |
| CHU La Rochelle Service de Pédiatrie - Rue du Dr Schweitzer | Recruiting |
| La Rochelle, France, 17000 | |
| Contact: Sophie TROLLER, MD 05 46 45 52 65 ext 33 sophie.troller@ch-larochelle.fr | |
| Principal Investigator: Sophie TROLLER, MD | |
| CHRU Lille Hôpital Jeanne de Flandre service de Pédiatrie | Recruiting |
| Lille, France, 59037 | |
| Contact: Jacques WEILL, MD 03 20 44 46 95 ext 33 jweill@chru-lille.fr | |
| Principal Investigator: Jacques WEILL, MD | |
| CHU Limoges Hôpital Mère Enfant Service Pédiatrie - 8, ave du Larrey | Recruiting |
| Limoges, France, 87042 | |
| Contact: Anne LIENHARDT-ROUSSIE, MD 05 55 05 63 58 ext 33 anne.lienhardt@chu-limoges.fr | |
| Principal Investigator: Anne LIENHARDT-ROUSSIE, MD | |
| CHU Lorient Hôpital du Scorff Pôle Femme Mère Enfant - Rue Guiguen | Recruiting |
| Lorient, France, 56100 | |
| Contact: Catherine NAUD-SAUDREAU, MD 02 97 64 33 77 ext 33 c.naud.saudreau@ch-bretagne-sud.fr | |
| Principal Investigator: Catherine NAUD-SAUDREAU, MD | |
| CHU Lyon Hôpital Debrousse service Pédiatrie | Recruiting |
| Lyon, France, 69322 | |
| Contact: Marc NICOLINO, MD 04 72 38 56 02 ext 33 marc.nicolino@chu-lyon.fr | |
| Principal Investigator: Marc NICOLINO, MD | |
| AP-HM Hôptal La Timone Service de Pédiatrie Mutidisciplinaire | Recruiting |
| Marseille, France, 13385 | |
| Contact: Gilbert SIMONIN, MD 04 91 38 67 30 ext 33 gilbert.simonin@ap-hm.fr | |
| Principal Investigator: Gilbert SIMONIN, MD | |
| CHU Montpellier Hôpital Arnaud de Villeneuve - 371 ave du doyen Gaston Giraud | Not yet recruiting |
| Montpellier, France, 34000 | |
| Contact: Claire JEANDEL, MD 04 67 33 66 34 ext 33 claire.jeandel@chu-montpellier.fr | |
| Principal Investigator: Claire JEANDEL, MD | |
| CHU Nantes Hôpital Mère Enfant Service de Pédiatrie | Not yet recruiting |
| Nantes, France, 44093 | |
| Contact: Sabine BARON, MD 02 40 08 34 80 ext 33 sabine.baron@chu-nantes.fr | |
| Principal Investigator: Sabine BARON, MD | |
| CHU Nice Hôpital Archet 2 - 151 route Saint Antoine de Ginestière | Recruiting |
| Nice, France, 06202 | |
| Contact: Jean-Christophe MAS, MD 04 92 03 60 74 ext 33 mas.jc@chu-nice.fr | |
| Principal Investigator: Jean-Christophe MAS, MD | |
| AP-HP Hôpital Necker Enfants Malades Service d'endocrinologie pédiatrique - 149 route de Sèvres | Recruiting |
| Paris, France, 75015 | |
| Contact: Graziella PINTO, MD 01 44 49 48 02 ext 33 grazielle.pinto@nck.aphp.fr | |
| Principal Investigator: Graziella PINTO, MD | |
| CHU Poitiers Service de Pédiatrie - Rue de la Miléterie | Recruiting |
| Poitiers, France, 86021 | |
| Contact: Kabangu KAYEMBA-KAY'S, MD 05 49 44 22 92 ext 33 k.kayemba-kays@chu-poitiers.fr | |
| Principal Investigator: Kabangu KAYEMBA-KAY'S, MD | |
| CHU Reims Service de Pédiatrie - 47, rue Cognacq-Jay | Recruiting |
| Reims, France, 51092 | |
| Contact: Véronique SULMONT, MD 03 26 78 81 99 ext 33 vsulmont@chu-reims.fr | |
| Principal Investigator: Véronique SULMONT, MD | |
| CHU Rouen Hôpital Nicolle - 1, rue de Germont | Not yet recruiting |
| Rouen, France, 76000 | |
| Contact: Eric MALLET, MD 02 32 88 82 13 ext 33 eric.mallet@chu-rouen.fr | |
| Principal Investigator: Eric MALLET, MD | |
| CHU Saint-Etienne Hôpital Nord Service de Pédiatrie | Recruiting |
| Saint-etienne, France, 42055 | |
| Contact: Catherine RAYNAUD-RAVNI, MD 04 77 82 80 33 ext 33 catherine.raynaud_ravni@chu-st-etienne.fr | |
| Principal Investigator: Catherine RAYNAUD-RAVNI, MD | |
| CHU Strasbourg Hôpital Haute-Pierre - Avenue Molière | Recruiting |
| Strasbourg, France, 67200 | |
| Contact: Sylvie SOSKIN, MD 03 88 12 77 34 ext 33 sylvie.soskin@chru-strasbourg.fr | |
| Principal Investigator: Sylvie SOSKIN, MD | |
| CHU Toulouse Hôpital des Enfants Service d'endocrinologie - 330 ave de Grande Bretagne | Recruiting |
| Toulouse, France, 31059 | |
| Contact: Maïthé TAUBER, MD 05 34 55 85 51 ext 33 tauber.m@chu-toulouse.fr | |
| Principal Investigator: Maïthé TAUBER, Professor | |
| Sub-Investigator: Jean-Pierre SALLES, MD | |
| Sub-Investigator: Gwenaëlle DIENE, MD | |
| CHRU Tours Centre de Pédiatrie Gatien de Clocheville | Not yet recruiting |
| Tours, France, 37044 | |
| Contact: François DESPERT, MD 02 47 47 38 68 ext 33 despert@med.univ-tours.fr | |
| Principal Investigator: François DESPERT, MD | |
| Hôpital d'Enfants - Rue Morvan | Recruiting |
| Vandoeuvre Les Nancy, France, 54511 | |
| Contact: Bruno LEHEUP, MD 03 83 15 46 15 ext 33 b.leheup@chu-nancy.fr | |
| Principal Investigator: Bruno LEHEUP, MD | |
| Principal Investigator: | Maithé TAUBER, MD | University Hospital, Toulouse |
More Information
No publications provided
| Responsible Party: | University Hospital, Toulouse |
| ClinicalTrials.gov Identifier: | NCT01298180 History of Changes |
| Other Study ID Numbers: | 0811601, National PHRC 2008 |
| Study First Received: | November 6, 2009 |
| Last Updated: | April 30, 2013 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by University Hospital, Toulouse:
|
Prader-Willi Syndrome Growth Hormone Deficiency |
Additional relevant MeSH terms:
|
Dwarfism, Pituitary Prader-Willi Syndrome Endocrine System Diseases Dwarfism Bone Diseases, Developmental Bone Diseases Musculoskeletal Diseases Bone Diseases, Endocrine Hypopituitarism Pituitary Diseases Hypothalamic Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Mental Retardation Neurobehavioral Manifestations Neurologic Manifestations Abnormalities, Multiple Congenital Abnormalities Chromosome Disorders Genetic Diseases, Inborn Obesity Overnutrition Nutrition Disorders Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013