Ignite Creation Date:
2025-12-25 @ 3:22 AM
Ignite Modification Date:
2025-12-26 @ 2:01 AM
Study NCT ID:
NCT00631605
Status:
COMPLETED
Last Update Posted:
2009-03-03
First Post:
2008-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Studies of Neuroendocrine and Energy Metabolism in Patients With Eating Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000856', 'term': 'Anorexia Nervosa'}, {'id': 'D052018', 'term': 'Bulimia Nervosa'}, {'id': 'D001068', 'term': 'Feeding and Eating Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-03-01', 'studyFirstSubmitDate': '2008-03-03', 'studyFirstSubmitQcDate': '2008-03-07', 'lastUpdatePostDateStruct': {'date': '2009-03-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['eating disorders', 'ghrelin', 'leptin', 'BIA'], 'conditions': ['Anorexia Nervosa', 'Bulimia Nervosa']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate neuroendocrine, autonomic functioning, and energy metabolism in patients with eating disorder and their relationships with psychopathology of eating disorders (eating patterns, depression, and personality) in these patients.', 'detailedDescription': 'The study subjects include female patients with DSM-IV diagnosis of AN (n = 30), BN (n = 60) and age-controled normal subjects (n = 30). They will receive a clinical interview and are asked to complete several self-administered questionnaires which included eating-related questionnaires, general psychological functioning scales and personality scales. After overnight fast, each subject undergoes a blood sample collection for neuroendocrine examination, body composition examination using BIA method, basal metabolic rate measurement by indirect calorimetry, and ECG in the morning between 0800 and 0900. Clinical patients would be asked to repeat filling the self-rating scales, weight and body fat measurement, as well as blood drawing again 2 months after treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with eating disorders and normal controls', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who fulfilled DSM-IV diagnosis of anorexia nervosa or bulimia nervosa\n* Normal controls\n\nExclusion Criteria:\n\n* Any major psychiatric disorders\n* Use of psychoactive medications\n* Drug and alcohol abuse\n* Medical problems (cardiovascular condition and endocrine disorders)'}, 'identificationModule': {'nctId': 'NCT00631605', 'briefTitle': 'Studies of Neuroendocrine and Energy Metabolism in Patients With Eating Disorders', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Studies of Neuroendocrine and Energy Metabolism in Patients With Eating Disorders', 'orgStudyIdInfo': {'id': '200705061R'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1'}, {'label': '2'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Mei-Chih Tseng, MD, Msc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Mei-Chih Tseng/Attending psychiatrist', 'oldOrganization': 'National Taiwan University Hospital'}}}}