Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT01351818
Status:
COMPLETED
Last Update Posted:
2011-05-11
First Post:
2011-05-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adipocyte Function and Somtropin Deficiency
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': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-10', 'studyFirstSubmitDate': '2011-05-02', 'studyFirstSubmitQcDate': '2011-05-10', 'lastUpdatePostDateStruct': {'date': '2011-05-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the potential influence of exogenous GH administration on adipocyte endocrine function (leptin, adiponectin, and resistin) and on ghrelin secretion', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Height assessment (using Harpenden stadiometer)', 'timeFrame': '1 year'}, {'measure': 'Weight assessment', 'timeFrame': '1 year'}, {'measure': 'BMI assessment', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Growth Hormone Deficiency']}, 'descriptionModule': {'briefSummary': 'To assess the influence of exogenous GH (growth hormone) administration on adipocyte endocrine function (leptin, adiponectin, and resistin) and on ghrelin secretion in children with delayed growth due to GH deficiency.\n\nStudy hypothesis: hormones produced by the adipocyte (leptin, adiponectin, and resistin) and ghrelin may exert a certain control on production of GH and IGF-I, and GH may in turn have a regulatory effect on such hormones.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children with GH deficiency', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children of both sexes aged from 5 to 12 years, Tanner stage 1, with no signs of imminent pubertal development. Amenable to treatment with recombinant somatropin in the approved indication of low growth due to GH deficiency\n* Selection of recombinant somatropin by the physician in the treatment authorization request, and subsequent approval of such treatment by the relevant growth hormone committee\n* Body Mass Index (BMI) within ±1 SD\n\nExclusion Criteria:\n\n* Children with any of the reported contraindications for treatment with recombinant somatropin, existence of active neoplasms, progression or recurrence of intracranial lesion, etc. will not be studied\n* Diabetes mellitus\n* Intestinal inflammatory disease\n* Celiac disease\n* Uncontrolled hyperthyroidism\n* AIDS\n* Other diseases causing chronic malabsorption, hypercatabolism or malnutrition conditions\n* Chronic liver disease\n* Eating disorders: anorexia, bulimia, etc\n* Long-term treatment with anti-obesity drugs or drugs causing malabsorption'}, 'identificationModule': {'nctId': 'NCT01351818', 'acronym': 'FAYDS', 'briefTitle': 'Adipocyte Function and Somtropin Deficiency', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ferring Pharmaceuticals'}, 'officialTitle': 'The Fayds Project: Adipocyte Function and Somtropin Deficiency', 'orgStudyIdInfo': {'id': 'FER-SOM-2004-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Growth hormone', 'description': 'Patients with a condition', 'interventionNames': ['Drug: Growth Hormone']}], 'interventions': [{'name': 'Growth Hormone', 'type': 'DRUG', 'armGroupLabels': ['Growth hormone']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Badajoz', 'state': 'Badajoz', 'country': 'Spain', 'facility': 'Investigational site', 'geoPoint': {'lat': 38.87789, 'lon': -6.97061}}, {'city': 'Don Benito', 'state': 'Badajoz', 'country': 'Spain', 'facility': 'Investigational site', 'geoPoint': {'lat': 38.95627, 'lon': -5.86162}}, {'city': 'Cáceres', 'state': 'Cáceres', 'country': 'Spain', 'facility': 'Investigational site', 'geoPoint': {'lat': 39.47649, 'lon': -6.37224}}, {'city': 'Cadiz', 'state': 'Cádiz', 'country': 'Spain', 'facility': 'Investigational site', 'geoPoint': {'lat': 36.52672, 'lon': -6.2891}}, {'city': 'Córdoba', 'state': 'Córdoba', 'country': 'Spain', 'facility': 'Investigational site', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'city': 'Granada', 'state': 'Granada', 'country': 'Spain', 'facility': 'Investigational site', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'city': 'Huelva', 'state': 'Huelva', 'country': 'Spain', 'facility': 'Investigational site', 'geoPoint': {'lat': 37.26638, 'lon': -6.94004}}, {'city': 'Jaén', 'state': 'Jaen', 'country': 'Spain', 'facility': 'Investigational site', 'geoPoint': {'lat': 37.76922, 'lon': -3.79028}}, {'city': 'Murcia', 'state': 'Murcia', 'country': 'Spain', 'facility': 'Investigational site', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}, {'city': 'Málaga', 'state': 'Málaga', 'country': 'Spain', 'facility': 'Investigational site', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'city': 'Seville', 'state': 'Sevilla', 'country': 'Spain', 'facility': 'Investigational site', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Santa Cruz de Tenerife', 'state': 'Tenerife', 'country': 'Spain', 'facility': 'Investigational site', 'geoPoint': {'lat': 28.46824, 'lon': -16.25462}}], 'overallOfficials': [{'name': 'Clinical Development Support', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ferring Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ferring Pharmaceuticals', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Ferring SAU', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Clinical Development Support', 'oldOrganization': 'Ferring Pharmaceuticals'}}}}