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| Sponsors and Collaborators: |
University Hospital, Angers Novo Nordisk |
|---|---|
| Information provided by: | University Hospital, Angers |
| ClinicalTrials.gov Identifier: | NCT00187993 |
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: | Natural History, Longitudinal, Defined Population, Prospective Study |
| 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:
Exclusion Criteria:
Contacts and Locations| France | |
| UH of Caen | Not yet recruiting |
| Caen, France | |
| Contact: Reznik reznyk-y@chu-caen.fr | |
| Principal Investigator: Reznik Yves, 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 | |
| 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 Limoges | Not yet recruiting |
| Limoges, France | |
| Contact: Tessier Marie-Pierre, Professor marie-pierre.tessier@chu-limoges.fr | |
| Principal Investigator: Tessier Marie-Pierre, Professor | |
| Study Director: | Rohmer Vincent, Professor | CHU of Angers |
More Information
| Study ID Numbers: | CP-04-03, 2004/10 (CCPPRB), 0673 (AFSSAPS) |
| Study First Received: | September 12, 2005 |
| Last Updated: | September 12, 2005 |
| ClinicalTrials.gov Identifier: | NCT00187993 History of Changes |
| Health Authority: | France : French Drug Agency |
|
growth hormone deficiency growth hormone energy expenditure body composition |
|
Dwarfism Bone Diseases, Endocrine Hypothalamic Diseases Hypopituitary Dwarfism Pituitary Diseases Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Endocrine System Diseases Central Nervous System Diseases |
Dwarfism, Pituitary Brain Diseases Hormones Bone Diseases Musculoskeletal Diseases Hypopituitarism Growth Hormone Deficiency Bone Diseases, Developmental Endocrinopathy |
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Dwarfism Bone Diseases, Endocrine Hypothalamic Diseases Pituitary Diseases Physiological Effects of Drugs Nervous System Diseases Hormones, Hormone Substitutes, and Hormone Antagonists Endocrine System Diseases Central Nervous System Diseases |
Dwarfism, Pituitary Brain Diseases Hormones Bone Diseases Pharmacologic Actions Musculoskeletal Diseases Hypopituitarism Bone Diseases, Developmental |