Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-25 @ 11:34 PM
Study NCT ID:
NCT00187993
Status:
UNKNOWN
Last Update Posted:
2005-09-16
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Growth Hormone Treatment of Young Growth Hormone-Deficient Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004393', 'term': 'Dwarfism, Pituitary'}], 'ancestors': [{'id': 'D004392', 'term': 'Dwarfism'}, {'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001849', 'term': 'Bone Diseases, Endocrine'}, {'id': 'D007018', 'term': 'Hypopituitarism'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D007027', 'term': 'Hypothalamic Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013006', 'term': 'Growth Hormone'}], 'ancestors': [{'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'DEFINED_POPULATION'}, 'enrollmentInfo': {'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-09', 'completionDateStruct': {'date': '2005-08'}, 'lastUpdateSubmitDate': '2005-09-12', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['growth hormone deficiency', 'growth hormone', 'energy expenditure', 'body composition'], 'conditions': ['Growth Hormone Deficiency']}, 'descriptionModule': {'briefSummary': '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.\n\nHowever, for patients deficient since childhood, no study have demonstrated that GH treatment during childhood present these same benefit when they are treated during adulthood.\n\nPrimary 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.\n\nWe 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).\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (age \\> 18-35 years)\n* Stable body mass +/- 5 kg in 3 months\n* GH deficiency since childhood, treated by GH during childhood, having stopped GH treatment at the end of adolescence\n* Want to receive again GH treatment or refusing new GH treatment\n* GH deficiency confirmed at adulthood by GHRH-Arginine test\n* Women receiving GH treatment must have a efficient contraceptive method\n* Have given a writing informed consent\n\nExclusion Criteria:\n\n* Somatotropic insufficiency\n* All pathologies or treatment modifing energetic metabolism, excepted diabet mellitus and obesity\n* Participating to another clinical trial during the three months befor inclusion\n* Pathologies modifing bone metabolism\n* Pregnancy/Feeding\n* Refusal to consent'}, 'identificationModule': {'nctId': 'NCT00187993', 'briefTitle': 'Growth Hormone Treatment of Young Growth Hormone-Deficient Adults', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': 'Growth Hormone Treatment of Young Adults Deficient in Growth Hormone Since Childhood : Study of Body Composition Modifications.', 'orgStudyIdInfo': {'id': 'CP-04-03'}, 'secondaryIdInfos': [{'id': '2004/10 (CCPPRB)'}, {'id': '0673 (AFSSAPS)'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Growth hormone', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '49000', 'city': 'Angers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Rohmer Vincent, Professor', 'role': 'CONTACT', 'email': 'virohmer@chu-angers.fr'}, {'name': 'Rohmer Vincent, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UH of Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Brest', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sonnet Emmanuel, Dr', 'role': 'CONTACT', 'email': 'emmanuel.sonnet@chu-brest.fr'}, {'name': 'Sonnet Emmanuel, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UH of Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'city': 'Caen', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Reznik', 'role': 'CONTACT', 'email': 'reznyk-y@chu-caen.fr'}, {'name': 'Reznik Yves, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UH of Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Limoges', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Tessier Marie-Pierre, Professor', 'role': 'CONTACT', 'email': 'marie-pierre.tessier@chu-limoges.fr'}, {'name': 'Tessier Marie-Pierre, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UH of Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '35000', 'city': 'Rennes', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Lorcy', 'role': 'CONTACT', 'email': 'yannick.lorcy@chu-rennes.fr'}], 'facility': 'UH of Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Tours', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Lecomte', 'role': 'CONTACT', 'email': 'lecomte@med.univ-tours.fr'}, {'name': 'Lecompte Pierre, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UH of Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'overallOfficials': [{'name': 'Rohmer Vincent, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CHU of Angers'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}]}}}