Growth Hormone Treatment of Young Growth Hormone-Deficient Adults

Condition(s) targeted: Growth Hormone Deficiency

Intervention: Growth hormone (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: University Hospital, Angers

Official(s) and/or principal investigator(s):
Rohmer Vincent, Professor, Study Director, Affiliation: CHU of Angers

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.

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

Study design: Natural History, Longitudinal, Defined Population, Prospective Study

Minimum age: 18 Years. Maximum age: 35 Years. Gender(s): Both.

Criteria:

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

UH of Caen, Caen, France; Not yet recruiting
Reznik, Email: reznyk-y@chu-caen.fr
Reznik Yves, Professor, Principal Investigator

UH of Rennes, Rennes 35000, France; Not yet recruiting
Lorcy, Email: yannick.lorcy@chu-rennes.fr

UH of Tours, Tours, France; Not yet recruiting
Lecomte, Email: lecomte@med.univ-tours.fr
Lecompte Pierre, Professor, Principal Investigator

UH of Limoges, Limoges, France; Not yet recruiting
Tessier Marie-Pierre, Professor, Email: marie-pierre.tessier@chu-limoges.fr
Tessier Marie-Pierre, Professor, Principal Investigator

UH of Brest, Brest, France; Not yet recruiting
Sonnet Emmanuel, Dr, Email: emmanuel.sonnet@chu-brest.fr
Sonnet Emmanuel, Doctor, Principal Investigator

UH of Angers, Angers 49000, France; Recruiting
Rohmer Vincent, Professor, Email: virohmer@chu-angers.fr
Rohmer Vincent, Professor, Principal Investigator

Starting date: May 2005
Ending date: August 2005
Last updated: September 12, 2005