Is There a Sensibility Increased in the Growth Hormone at Child With Prader-Willi Syndrome?
Overview
- Phase
- Phase 4
- Intervention
- Growth hormone (Genotonorm® or Omnitrope®)
- Conditions
- Prader-Willi Syndrome
- Sponsor
- University Hospital, Toulouse
- Enrollment
- 111
- Locations
- 26
- Primary Endpoint
- Measure of the circulating rates of IGF-I under treatment.
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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).
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.
Investigators
Eligibility Criteria
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
- •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
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)
Arms & Interventions
SPW
Children presenting a Prader-Willi Syndrome
Intervention: Growth hormone (Genotonorm® or Omnitrope®)
SPW
Children presenting a Prader-Willi Syndrome
Intervention: DEXA, blood tests, H.G.P.O, osseous age.
GHD
Patient deficient in Growth Hormone
Intervention: Growth hormone (Genotonorm® or Omnitrope®)
GHD
Patient deficient in Growth Hormone
Intervention: DEXA, blood tests, H.G.P.O, osseous age.
SPW-B
Patient with Prader-Willi Syndrome who has Biopsy
Intervention: Growth hormone (Genotonorm® or Omnitrope®)
SPW-B
Patient with Prader-Willi Syndrome who has Biopsy
Intervention: DEXA, blood tests, H.G.P.O, osseous age.
SPW-B
Patient with Prader-Willi Syndrome who has Biopsy
Intervention: biopsy
T
Patient Control
Intervention: biopsy
SPW-GH-B
Patient with Prader-Willi Syndrome taking growth Hormone and who has biopsy
Intervention: biopsy
Outcomes
Primary Outcomes
Measure of the circulating rates of IGF-I under treatment.
Time Frame: 1 year (M12)
Secondary Outcomes
- Measure of blood sugar level, H.G.P.O., and hyperglycaemia.(1 year (M12))
- Measure of the circulating rate of IGFBP-3, GHBP, ghrelin and apelin.(1 year (M12))
- Measure of physical composition's variation.(1 year (M12))
- Measure of the sensibility at the growth hormone in vitro, on fibroblasts and adipocytes obtained by biopsy.(1 year (M12))