Growth Hormone Treatment of Young Growth Hormone-Deficient Adults

• Conditions: Growth Hormone Deficiency

• Registration Number: NCT00187993
• Lead Sponsor: University Hospital, Angers

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Study Completion: 2005-08
• Status Verified: 2005-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Last Update Submitted: 2005-09-12
• Study First Posted: 2005-09-16
• Last Update Posted: 2005-09-16

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (6)

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, France