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

• Register: ClinicalTrials.gov
• Last refreshed on: 27 September 2021
• Main ID: NCT01298180
• Date of registration: 06/11/2009
• Prospective Registration: No
• Primary sponsor: University Hospital, Toulouse
• Public title: Is There a Sensibility Increased in the Growth Hormone at Child With Prader-Willi Syndrome?
• Scientific title: Is There a Sensibility Increased in the Growth Hormone at Child With Prader-Willi Syndrome?
• Date of first enrolment: January 2009
• Target sample size: 111
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01298180
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

France

Contacts

• Name: Maithé TAUBER, MD
• Affiliation: University Hospital, Toulouse

Key inclusion & exclusion 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



Age minimum: 1 Year
Age maximum: 5 Years
Gender: All

Health Condition(s) or Problem(s) studied

Prader-Willi Syndrome

Growth Hormone Deficiency

Intervention(s)

Drug: Growth hormone (Genotonorm® or Omnitrope®)

Procedure: DEXA, blood tests, H.G.P.O, osseous age.

Procedure: biopsy

Primary Outcome(s)

Measure of the circulating rates of IGF-I under treatment. [Time Frame: 1 year (M12)]

Measure of the circulating rates of IGF-I under treatment. [Time Frame: 1 month (M1)]

Measure of the circulating rates of IGF-I under treatment. [Time Frame: 6 month (M6)]

Measure of the circulating rates of IGF-I under treatment. [Time Frame: Before starting treatment: baseline (J0)]

Measure of the circulating rates of IGF-I under treatment. [Time Frame: 3 month (M3)]

Secondary Outcome(s)

Measure of the sensibility at the growth hormone in vitro, on fibroblasts and adipocytes obtained by biopsy. [Time Frame: 1 year (M12)]

Measure of the sensibility at the growth hormone in vitro, on fibroblasts and adipocytes obtained by biopsy. [Time Frame: 3 months (M3)]

Measure of the sensibility at the growth hormone in vitro, on fibroblasts and adipocytes obtained by biopsy. [Time Frame: Before starting treatment (J0)]

Measure of physical composition's variation. [Time Frame: 3 months (M3)]

Measure of blood sugar level, H.G.P.O., and hyperglycaemia. [Time Frame: 6 months (M6)]

Measure of the circulating rate of IGFBP-3, GHBP, ghrelin and apelin. [Time Frame: 1 year (M12)]

Measure of the circulating rate of IGFBP-3, GHBP, ghrelin and apelin. [Time Frame: 3 months (M3)]

Measure of the sensibility at the growth hormone in vitro, on fibroblasts and adipocytes obtained by biopsy. [Time Frame: 6 months (M6)]

Measure of physical composition's variation. [Time Frame: Before starting treatment (J0)]

Measure of the circulating rate of IGFBP-3, GHBP, ghrelin and apelin. [Time Frame: Before starting treatment (J0)]

Measure of blood sugar level, H.G.P.O., and hyperglycaemia. [Time Frame: Before starting treatment (J0)]

Measure of physical composition's variation. [Time Frame: 6 months (M6)]

Measure of the circulating rate of IGFBP-3, GHBP, ghrelin and apelin. [Time Frame: 6 months (M6)]

Measure of blood sugar level, H.G.P.O., and hyperglycaemia. [Time Frame: 1 year (M12)]

Measure of blood sugar level, H.G.P.O., and hyperglycaemia. [Time Frame: 3 months (M3)]

Measure of physical composition's variation. [Time Frame: 1 year (M12)]

Secondary ID(s)

National PHRC 2008

0811601

Source(s) of Monetary Support

Please refer to primary and secondary sponsors