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

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ClinicalTrials.gov Identifier: NCT01298180
Recruitment Status : Completed
First Posted : February 17, 2011
Last Update Posted : September 24, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief 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).

Condition or disease Intervention/treatment 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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Is There a Sensibility Increased in the Growth Hormone at Child With Prader-Willi Syndrome?
Study Start Date : January 2009
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Measure of the circulating rates of IGF-I under treatment. [ Time Frame: Before starting treatment: baseline (J0) ]
  2. Measure of the circulating rates of IGF-I under treatment. [ Time Frame: 1 month (M1) ]
  3. Measure of the circulating rates of IGF-I under treatment. [ Time Frame: 3 month (M3) ]
  4. Measure of the circulating rates of IGF-I under treatment. [ Time Frame: 6 month (M6) ]
  5. Measure of the circulating rates of IGF-I under treatment. [ Time Frame: 1 year (M12) ]

Secondary Outcome Measures :
  1. Measure of the circulating rate of IGFBP-3, GHBP, ghrelin and apelin. [ Time Frame: Before starting treatment (J0) ]
  2. Measure of physical composition's variation. [ Time Frame: Before starting treatment (J0) ]
  3. Measure of blood sugar level, H.G.P.O., and hyperglycaemia. [ Time Frame: Before starting treatment (J0) ]
  4. Measure of the sensibility at the growth hormone in vitro, on fibroblasts and adipocytes obtained by biopsy. [ Time Frame: Before starting treatment (J0) ]
  5. Measure of the circulating rate of IGFBP-3, GHBP, ghrelin and apelin. [ Time Frame: 3 months (M3) ]
  6. Measure of the circulating rate of IGFBP-3, GHBP, ghrelin and apelin. [ Time Frame: 6 months (M6) ]
  7. Measure of the circulating rate of IGFBP-3, GHBP, ghrelin and apelin. [ Time Frame: 1 year (M12) ]
  8. Measure of physical composition's variation. [ Time Frame: 3 months (M3) ]
  9. Measure of physical composition's variation. [ Time Frame: 6 months (M6) ]
  10. Measure of physical composition's variation. [ Time Frame: 1 year (M12) ]
  11. Measure of blood sugar level, H.G.P.O., and hyperglycaemia. [ Time Frame: 3 months (M3) ]
  12. Measure of blood sugar level, H.G.P.O., and hyperglycaemia. [ Time Frame: 6 months (M6) ]
  13. Measure of blood sugar level, H.G.P.O., and hyperglycaemia. [ Time Frame: 1 year (M12) ]
  14. Measure of the sensibility at the growth hormone in vitro, on fibroblasts and adipocytes obtained by biopsy. [ Time Frame: 3 months (M3) ]
  15. Measure of the sensibility at the growth hormone in vitro, on fibroblasts and adipocytes obtained by biopsy. [ Time Frame: 6 months (M6) ]
  16. Measure of the sensibility at the growth hormone in vitro, on fibroblasts and adipocytes obtained by biopsy. [ Time Frame: 1 year (M12) ]


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Ages Eligible for Study:   1 Year to 5 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01298180


Locations
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Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Maithé TAUBER, MD University Hospital, Toulouse
Publications of Results:
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01298180    
Other Study ID Numbers: 0811601
National PHRC 2008 ( Other Grant/Funding Number: PHRC 2008 )
First Posted: February 17, 2011    Key Record Dates
Last Update Posted: September 24, 2021
Last Verified: September 2021
Keywords provided by University Hospital, Toulouse:
Prader-Willi Syndrome
Growth Hormone Deficiency
Additional relevant MeSH terms:
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Prader-Willi Syndrome
Syndrome
Disease
Pathologic Processes
Nervous System Diseases
Intellectual Disability
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