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Trial · Interventional

CompletedPhase 4Registry data

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

NCTNCT01298180 (opens ClinicalTrials.gov in a new tab)Other id0811601Other idNational PHRC 2008

Overview

Status
Completed
Phase
Phase 4
Enrollment
111 participants (actual)
Sponsor
University Hospital, Toulouse · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

France

Start
Jan 2009
Primary completion
May 2013
Completion
May 2013
First posted
17 Feb 2011 (estimated)
Last update posted
24 Sept 2021
Conditions
Prader-Willi Syndrome · Growth Hormone Deficiency

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200920102011201220132014
  1. Ph 4

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

    NCT01298180

    Jan 2009 to May 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

  • Growth hormone (Genotonorm® or Omnitrope®)Drug
  • DEXA, blood tests, H.G.P.O, osseous age.Procedure
  • biopsyProcedure

Arms5

  • Experimental

    SPW

    Children presenting a Prader-Willi Syndrome

  • Experimental

    GHD

    Patient deficient in Growth Hormone

  • Experimental

    SPW-B

    Patient with Prader-Willi Syndrome who has Biopsy

  • Experimental

    T

    Patient Control

  • Experimental

    SPW-GH-B

    Patient with Prader-Willi Syndrome taking growth Hormone and who has biopsy

Primary outcomes5

Outcomes the sponsor listed as primary.

  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 outcomes(16)
  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)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies3

Studies that cite this trial.

More studies

3 studies on this page

PubMed tag: none · 2024

Differential DNA methylation in iPSC-derived dopaminergic neurons: a step forward on the role of SNORD116 microdeletion in the pathophysiology of addictive behavior in Prader-Willi syndrome.

Salles et al. 2024Molecular psychiatrycited by 6

PMID 38561465DOI 10.1038/s41380-024-02542-4PUB-38561465

Rights unknown
Source link

PubMed tag: none · 2021

SNORD116 and growth hormone therapy impact IGFBP7 in Prader-Willi syndrome.

Eddiry et al. 2021Genetics in medicine : official journal of the American College of Medical Geneticscited by 13

PMID 34040195PMC8460435DOI 10.1038/s41436-021-01185-yPUB-34040195

CC BY
Download PDF

PubMed tag: none · 2014

Impairment of adipose tissue in Prader-Willi syndrome rescued by growth hormone treatment.

Cadoudal et al. 2014International journal of obesity (2005)cited by 24

PMID 24406482DOI 10.1038/ijo.2014.3PUB-24406482

Rights unknown
Source link

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultBieth E, Eddiry S, Gaston V, Lorenzini F, Buffet A, Conte Auriol F, Molinas C, Cailley D, Rooryck C, Arveiler B, Cavaille J, Salles JP, Tauber M. Highly restricted deletion of the SNORD116 region is implicated in Prader-Willi Syndrome. Eur J Hum Genet. 2015 Feb;23(2):252-5. doi: 10.1038/ejhg.2014.103. Epub 2014 Jun 11. PMID 24916642

Eligibility

Who could join, as posted.

Sex
All
Age
from 1 Year up to 5 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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