- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00187993
Growth Hormone Treatment of Young Growth Hormone-Deficient Adults
Growth Hormone Treatment of Young Adults Deficient in Growth Hormone Since Childhood : Study of Body Composition Modifications.
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.
Study Overview
Study Type
Enrollment
Contacts and Locations
Study Locations
-
-
-
Angers, France, 49000
- Recruiting
- UH of Angers
-
Contact:
- Rohmer Vincent, Professor
- Email: virohmer@chu-angers.fr
-
Principal Investigator:
- Rohmer Vincent, Professor
-
Brest, France
- Not yet recruiting
- UH of Brest
-
Contact:
- Sonnet Emmanuel, Dr
- Email: emmanuel.sonnet@chu-brest.fr
-
Principal Investigator:
- Sonnet Emmanuel, Doctor
-
Caen, France
- Not yet recruiting
- UH of Caen
-
Contact:
- Reznik
- Email: reznyk-y@chu-caen.fr
-
Principal Investigator:
- Reznik Yves, Professor
-
Limoges, France
- Not yet recruiting
- UH of Limoges
-
Contact:
- Tessier Marie-Pierre, Professor
- Email: marie-pierre.tessier@chu-limoges.fr
-
Principal Investigator:
- Tessier Marie-Pierre, Professor
-
Rennes, France, 35000
- Not yet recruiting
- UH of Rennes
-
Contact:
- Lorcy
- Email: yannick.lorcy@chu-rennes.fr
-
Tours, France
- Not yet recruiting
- UH of Tours
-
Contact:
- Lecomte
- Email: lecomte@med.univ-tours.fr
-
Principal Investigator:
- Lecompte Pierre, Professor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Defined Population
- Time Perspectives: Prospective
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Rohmer Vincent, Professor, CHU of Angers
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CP-04-03
- 2004/10 (CCPPRB)
- 0673 (AFSSAPS)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Growth Hormone Deficiency
-
Novo Nordisk A/SCompletedGrowth Hormone Disorder | Adult Growth Hormone DeficiencyFrance
-
Novo Nordisk A/SCompletedGrowth Hormone Disorder | Adult Growth Hormone DeficiencyDenmark
-
Novo Nordisk A/SCompletedGrowth Hormone Disorder | Adult Growth Hormone DeficiencyGermany
-
Novo Nordisk A/SCompletedGrowth Hormone Disorder | Growth Hormone Deficiency in ChildrenIsrael, Denmark, Belgium, Spain, Macedonia, The Former Yugoslav Republic of, Turkey, United Kingdom, France, Slovenia, Czech Republic
-
Novo Nordisk A/SWithdrawnGrowth Hormone Disorder | Growth Hormone Deficiency in Children
-
Novo Nordisk A/SCompletedHealthy | Growth Hormone Disorder | Adult Growth Hormone DeficiencyUnited States
-
Teva Pharmaceutical Industries, Ltd.TerminatedGrowth Hormone-DeficiencyBelarus, Bulgaria, Georgia, Greece, Hungary, Israel, Poland, Romania, Russian Federation, Serbia, Spain, Turkey, Ukraine
-
OPKO Health, Inc.CompletedSafety and Efficacy Phase 2 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient ChildrenPediatric Growth Hormone DeficiencyGreece, Hungary, Slovakia
-
Novo Nordisk A/SCompletedGrowth Hormone Disorder | Growth Hormone Deficiency in Children | Delivery SystemsGermany, Netherlands, Sweden
-
OPKO Health, Inc.CompletedAdult Growth Hormone DeficiencyCzechia, Hungary, Israel, Serbia, Slovakia, Slovenia
Clinical Trials on Growth hormone
-
The University of Texas Medical Branch, GalvestonCompletedMild Cognitive ImpairmentUnited States
-
University of PennsylvaniaNational Institute on Aging (NIA)TerminatedAging | Hormone DeficiencyUnited States
-
Massachusetts General HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
University of WashingtonNational Institute on Aging (NIA)CompletedAging | Mild Cognitive ImpairmentUnited States
-
Massachusetts General HospitalCompleted
-
Massachusetts General HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedHealthy VolunteersUnited States
-
University of PennsylvaniaCompletedCongestive Heart FailureUnited States
-
Versartis Inc.Completed
-
Rabin Medical CenterPfizerCompleted
-
Massachusetts General HospitalActive, not recruitingObesity | Fatty Liver | Liver Fat | Obesity, Abdominal | Non-Alcoholic Fatty Liver DiseaseUnited States