Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-25 @ 1:19 PM
Study NCT ID:
NCT01572259
Status:
UNKNOWN
Last Update Posted:
2015-11-17
First Post:
2011-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of the Role of the Growth Hormone (GH) Onthe Intestinal Triglyceride-rich-lipoproteins (TRL) Metabolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular 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': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-11-16', 'studyFirstSubmitDate': '2011-10-06', 'studyFirstSubmitQcDate': '2012-04-04', 'lastUpdatePostDateStruct': {'date': '2015-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To measure of Growth hormone', 'timeFrame': '3 YEARS', 'description': 'that growth hormone modulates directly, or indirectly by the changes of insulin sensitivity'}], 'secondaryOutcomes': [{'measure': 'to measure the adipocytokines levels (leptin, adiponectin, resistin) the metabolism (production and/or clearance) of the intestinal TRL', 'timeFrame': '3 YEARS'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Atherosclerotic Cardiovascular Disease']}, 'referencesModule': {'references': [{'pmid': '34462238', 'type': 'DERIVED', 'citation': 'Maraninchi M, Calabrese A, Nogueira JP, Castinetti F, Mancini J, Mourre F, Pietri L, Benamo E, Albarel F, Morange I, Dupont-Roussel J, Nicolay A, Brue T, Beliard S, Valero R. Role of growth hormone in hepatic and intestinal triglyceride-rich lipoprotein metabolism. J Clin Lipidol. 2021 Sep-Oct;15(5):712-723. doi: 10.1016/j.jacl.2021.08.003. Epub 2021 Aug 16.'}]}, 'descriptionModule': {'briefSummary': 'Atherosclerotic cardiovascular disease (ASCD) is the first cause of morbidity and mortality in insulin resistant states. The typical dyslipidemia that is associated with insulin resistance, which includes a postprandial increase of triglyceride-rich lipoproteins (TRL) with excess of intestinal triglyceride-rich-lipoprotein-apoB-48 (TRL-apoB-48), is felt to play an important role in the accelerated ASCD. Recently, intestinal TRL-apoB-48 overproduction appeared as a newly recognized component of insulin resistance. There is only a limited amount of information in the literature regarding the factors and the mechanisms modulating the metabolism of intestinal TRL-apoB-48 in the setting of insulin resistance'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMale or feminine\n\n* age from 18 to 70 years\n* deficit in growth hormone informed by a peak lower than 10 mUI / l in answer to a test of hypoglycemia (or another test of stimulation if the hypoglycemia insulinique is dissuaded) (cf. attached the RCP of various growth hormone used at the adult)\n* centre (treatments optimized previously will be maintained during all the duration of the study) thyréotrope, corticotrope and gonadotrope substituted well for at least 6 months\n* IMC(CEREBRAL-MOTOR HANDICAPPED) \\< 30 kg / m2\n* fasting blood glucose \\< 1,26 g/L\n* clearance of the creatinine \\> 60 ml / min\n\nExclusion Criteria:\n\nNobody particularly protected: incapable major and private person of freedom, person hospitalized for another pathology; · nobody mastering the reading of the French language\n\n* carrier patients of a tumor in service\n* pregnant woman'}, 'identificationModule': {'nctId': 'NCT01572259', 'briefTitle': 'Assessment of the Role of the Growth Hormone (GH) Onthe Intestinal Triglyceride-rich-lipoproteins (TRL) Metabolism', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'officialTitle': 'Assessment of the Role of the Growth Hormone (GH) Onthe Intestinal Triglyceride-rich-lipoproteins (TRL) Metabolism', 'orgStudyIdInfo': {'id': '2011-001688-34'}, 'secondaryIdInfos': [{'id': '2011-07', 'type': 'OTHER', 'domain': 'AP HM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'interruption of the growth hormone treatment.', 'interventionNames': ['Other: interruption of the traitment with growth hormone']}, {'type': 'EXPERIMENTAL', 'label': 'Patients traited by grouth hormone', 'interventionNames': ['Drug: Growth Hormone']}], 'interventions': [{'name': 'Growth Hormone', 'type': 'DRUG', 'armGroupLabels': ['Patients traited by grouth hormone']}, {'name': 'interruption of the traitment with growth hormone', 'type': 'OTHER', 'armGroupLabels': ['interruption of the growth hormone treatment.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13354', 'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'rene Valero', 'role': 'CONTACT', 'email': 'rene.valero@ap-hm.fr', 'phone': '0491387572'}, {'name': 'rene VALERO', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Assistance Publique Hopitaux de Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'centralContacts': [{'name': 'RENE VALERO', 'role': 'CONTACT', 'email': 'rene.valero@ap-hm.fr'}], 'overallOfficials': [{'name': 'BERNARD BELAIGUES', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique hôpitaux de Marseille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}