Ignite Creation Date:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2026-01-06 @ 9:01 PM
Study NCT ID:
NCT03151135
Status:
TERMINATED
Last Update Posted:
2019-05-01
First Post:
2017-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Energy Turnover in Patients 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Funding period expired before all subjects could be recrutied', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-29', 'studyFirstSubmitDate': '2017-04-07', 'studyFirstSubmitQcDate': '2017-05-11', 'lastUpdatePostDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resting Energy expenditure (REE; kcal/d); Total Daily Energy Expenditure (TDEE; kcal/d)', 'timeFrame': 'End of inpatient treatment (T0), within 2 weeks before discharge', 'description': 'REE will be measured in a Respiration chamber and TDEE with isotope dilution'}], 'secondaryOutcomes': [{'measure': 'Body weight', 'timeFrame': 'T1 = 6 months after first test (T0)', 'description': 'Body weight 6 months after discharge from inpatient Treatment (T1)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Energy metabolism'], 'conditions': ['Anorexia Nervosa']}, 'descriptionModule': {'briefSummary': 'Pilot study to assess energy turnover at end of inpatient treatment in 10 patients with Anorexia nervosa.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '36 Years', 'minimumAge': '13 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Anorexia nervosa', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Anorexia nervosa\n* anabolic metabolism\n* high compliance\n* end of inpatient treatment\n\nExclusion Criteria:\n\n* any further disease than eating disorder\n* smokers'}, 'identificationModule': {'nctId': 'NCT03151135', 'briefTitle': 'Energy Turnover in Patients With Anorexia Nervosa', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Does Energy Turnover After Short-term Nutritional Recovery Predict Subsequent Weight Course in Patients With Anorexia Nervosa?', 'orgStudyIdInfo': {'id': 'DLW_AN'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'AN patients', 'description': 'Patients with Anorexia Nervosa (AN). No intervention, observation at end of inpatient treatment'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité-Universitätsmedizin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'collaborators': [{'name': 'German Research Foundation', 'class': 'OTHER'}, {'name': 'Hannover Medical School', 'class': 'OTHER'}, {'name': 'Ruhr University of Bochum', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. oec. troph. Verena Haas, PhD', 'investigatorFullName': 'Dr. Verena Haas', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}