Growth Hormone Treatment of Young Growth Hormone-Deficient Adults

Growth Hormone Deficiency Clinical Trial

Official title:

Growth Hormone Treatment of Young Adults Deficient in Growth Hormone Since Childhood : Study of Body Composition Modifications.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00187993
• Other study ID #: CP-04-03
• Secondary ID: 2004/10 (CCPPRB)
• Status: Recruiting
• Phase: N/A
• First received: September 12, 2005
• Last updated: September 12, 2005
• Start date: May 2005
• Est. completion date: August 2005

Study information

• Verified date: September 2005
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Health authority: France : French Drug Agency
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Dwarfism, Pituitary
• Endocrine System Diseases
• Growth Hormone Deficiency

Intervention

Drug:
• Growth hormone

Locations

Country	Name	City	State
France	UH of Angers	Angers
France	UH of Brest	Brest
France	UH of Caen	Caen
France	UH of Limoges	Limoges
France	UH of Rennes	Rennes
France	UH of Tours	Tours

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Angers	Novo Nordisk A/S

Country where clinical trial is conducted

France,