Is There a Sensibility Increased in the Growth Hormone at Child With Prader-Willi Syndrome?

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by University Hospital, Toulouse
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01298180
First received: November 6, 2009
Last updated: April 30, 2013
Last verified: April 2013
  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?

Resource links provided by NLM:


Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.

Procedure: biopsy
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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01298180

Contacts
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

Locations
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         
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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:
Prader-Willi Syndrome
Dwarfism, Pituitary
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 July 22, 2014