Growth Hormone Treatment of Young Growth Hormone-Deficient Adults
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Growth Hormone Deficiency |
Drug: Growth hormone |
| Study Type: | Observational |
| Study Design: | Observational Model: Defined Population Observational Model: Natural History Time Perspective: Longitudinal Time Perspective: Prospective |
| Official Title: | Growth Hormone Treatment of Young Adults Deficient in Growth Hormone Since Childhood : Study of Body Composition Modifications. |
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| France | |
| UH of Angers | Recruiting |
| Angers, France, 49000 | |
| Contact: Rohmer Vincent, Professor virohmer@chu-angers.fr | |
| Principal Investigator: Rohmer Vincent, Professor | |
| UH of Brest | Not yet recruiting |
| Brest, France | |
| Contact: Sonnet Emmanuel, Dr emmanuel.sonnet@chu-brest.fr | |
| Principal Investigator: Sonnet Emmanuel, Doctor | |
| UH of Caen | Not yet recruiting |
| Caen, France | |
| Contact: Reznik reznyk-y@chu-caen.fr | |
| Principal Investigator: Reznik Yves, Professor | |
| UH of Limoges | Not yet recruiting |
| Limoges, France | |
| Contact: Tessier Marie-Pierre, Professor marie-pierre.tessier@chu-limoges.fr | |
| Principal Investigator: Tessier Marie-Pierre, Professor | |
| UH of Rennes | Not yet recruiting |
| Rennes, France, 35000 | |
| Contact: Lorcy yannick.lorcy@chu-rennes.fr | |
| UH of Tours | Not yet recruiting |
| Tours, France | |
| Contact: Lecomte lecomte@med.univ-tours.fr | |
| Principal Investigator: Lecompte Pierre, Professor | |
| Study Director: | Rohmer Vincent, Professor | CHU of Angers |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00187993 History of Changes |
| Other Study ID Numbers: | CP-04-03, 2004/10 (CCPPRB), 0673 (AFSSAPS) |
| Study First Received: | September 12, 2005 |
| Last Updated: | September 12, 2005 |
| Health Authority: | France : French Drug Agency |
Keywords provided by University Hospital, Angers:
|
growth hormone deficiency growth hormone energy expenditure body composition |
Additional relevant MeSH terms:
|
Dwarfism, Pituitary Endocrine System Diseases Dwarfism Bone Diseases, Developmental Bone Diseases Musculoskeletal Diseases Bone Diseases, Endocrine Hypopituitarism Pituitary Diseases |
Hypothalamic Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013