Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2025-12-29 @ 1:22 PM
Study NCT ID:
NCT00825461
Status:
COMPLETED
Last Update Posted:
2018-01-09
First Post:
2009-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ghrelin With Anorexia Nervosa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000856', 'term': 'Anorexia Nervosa'}], 'ancestors': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2012-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-05', 'studyFirstSubmitDate': '2009-01-20', 'studyFirstSubmitQcDate': '2009-01-20', 'lastUpdatePostDateStruct': {'date': '2018-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-01-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concentration of ghrelin in blood.', 'timeFrame': '1 morning'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Anorexia Nervosa'], 'conditions': ['Anorexia Nervosa']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Bosse, T.; Delfos., M.F.; Jonker, C.M. & Treur, J. (2003). Reasoning about adaptive Dynamical Systems in the Analysis of eating Regulation Disorders. N.J. Mahwah. Proceedings of the 25th Annual Conference of the Cognitive Science Society. Lawrence Erlbaum Associates Inc.'}, {'type': 'BACKGROUND', 'citation': 'Both, F. & Delfos, M.F. (in preparation). The role of ghrelin in eating disorders, a review.'}]}, 'descriptionModule': {'briefSummary': 'The PICOWO research group in corporation with the University of Amsterdam (Artificial Intelligence) has developed a computer simulationmodel of eating disorders (Bosse, Delfos, Jonker \\& Treur, 2003). In a running Phd project we want to add ghrelin to the model. The idea for this current research is to collect clinical information about the functioning and (patho)physiology of ghrelin in patients with AN, so we can extend the simulation.', 'detailedDescription': 'Eating disorders are in need of new perspectives. A better understanding of the appetite in patients with eating disorders, especially Anorexia Nervosa, could be investigated by the levels of ghrelin in patients with and without tube feeding.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '35 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Studypopulation: Patiënts: all female, non -age coupled. Subgroup patients without tube feeding, with tube feeding and a healthy matched control group.\n\nControl group: healthy volunteers of the University of Maastricht.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Studypopulation: Patiënts: all female, non -age coupled.\n* Subgroup patients without tube feeding, with tube feeding and a healthy matched control group.\n* Control group: healty volunteers of the University of Maastricht.\n\nExclusion Criteria:\n\n* Patients with a history of eating disorder different than AN or a psychiatric history.\n* Control group: no history of eating disorders or other psychiatric disabilities. Normal physical examination, ecg, laboratorium (blood cells, liver, kidneys)'}, 'identificationModule': {'nctId': 'NCT00825461', 'briefTitle': 'Ghrelin With Anorexia Nervosa', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Level of Ghrelin With Anorexia Nervosa (AN) Patients. Subgroup AN: With and Without Tubefeeding.', 'orgStudyIdInfo': {'id': '08-3-089'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Anorexia with tube feeding'}, {'label': '2', 'description': 'Anorexia without tube feeding'}, {'label': '3', 'description': 'Control'}]}, 'contactsLocationsModule': {'locations': [{'zip': '6202 AZ', 'city': 'Maastricht', 'state': 'Limburg', 'country': 'Netherlands', 'facility': 'University Hospital Maastricht', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'Martine F Delfos, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PICOWO Utrecht'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}