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Growth Hormone Treatment of Young Growth Hormone-Deficient Adults
This study is currently recruiting participants.
Study NCT00187993   Information provided by University Hospital, Angers
First Received: September 12, 2005   No Changes Posted

September 12, 2005
September 12, 2005
May 2005
 
 
 
No Changes Posted
 
 
 
Growth Hormone Treatment of Young Growth Hormone-Deficient Adults
Growth Hormone Treatment of Young Adults Deficient in Growth Hormone Since Childhood : Study of Body Composition Modifications.

Hypopituitary adults with all the hormonal deficiencies are well subsituted excepted for the growth hormone (GH) and died earlier than the rest of the population. GH deficiency involves a fat mass increase with regard to lean mass, an atherogenic lipidic profile and participating to osteopenia mechanism and decrease the life quality. All these dysfunctions are partially or totally corrected by the GH prescription with patient deficient since adulthood.

However, for patients deficient since childhood, no study have demonstrated that GH treatment during childhood present these same benefit when they are treated during adulthood.

Primary objective of this study is to examine that fat mass significantly decrease due to GH treatment in adulthood for patient GH deficient since childhood, treated by GH during childhood but stopped since the end of adolescence.

We compare the body composition and others energetic metabolism parameters in two patient groups, one treated by GH during 18 months, and the other with no treatment. Body composition and bone density are measured by pletysmography (DEXA). Metabolic parameters are : energetic balance (energy intake evaluation by questionnaire, energetic expenditure evaluated by doubly labelled water) and biologic parameters (lipidic profile, thyroid hormones).

This study will evaluate if the GH treatment of young GH deficient adults since childhood can be a benefit for body composition, lipidic profile and bone density.

 
 
Observational
Natural History, Longitudinal, Defined Population, Prospective Study
Growth Hormone Deficiency
Drug: Growth hormone
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
30
August 2005
 

Inclusion Criteria:

  • Adults (age > 18-35 years)
  • Stable body mass +/- 5 kg in 3 months
  • GH deficiency since childhood, treated by GH during childhood, having stopped GH treatment at the end of adolescence
  • Want to receive again GH treatment or refusing new GH treatment
  • GH deficiency confirmed at adulthood by GHRH-Arginine test
  • Women receiving GH treatment must have a efficient contraceptive method
  • Have given a writing informed consent

Exclusion Criteria:

  • Somatotropic insufficiency
  • All pathologies or treatment modifing energetic metabolism, excepted diabet mellitus and obesity
  • Participating to another clinical trial during the three months befor inclusion
  • Pathologies modifing bone metabolism
  • Pregnancy/Feeding
  • Refusal to consent
Both
18 Years to 35 Years
No
 
France
 
NCT00187993
 
CP-04-03, 2004/10 (CCPPRB), 0673 (AFSSAPS)
University Hospital, Angers
Novo Nordisk
Study Director: Rohmer Vincent, Professor CHU of Angers
University Hospital, Angers
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP