Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2026-01-02 @ 1:34 AM
Study NCT ID:
NCT03334032
Status:
COMPLETED
Last Update Posted:
2017-11-07
First Post:
2017-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incomplete Total Body Protein Recovery in Adolescent 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006760', 'term': 'Hospitalization'}], 'ancestors': [{'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 154}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-02', 'studyFirstSubmitDate': '2017-10-29', 'studyFirstSubmitQcDate': '2017-11-02', 'lastUpdatePostDateStruct': {'date': '2017-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Total Body protein', 'timeFrame': 'Between baseline (inpatient admission) and at 7 months follow-up', 'description': 'Change in Total Body protein'}], 'secondaryOutcomes': [{'measure': 'Change in body weight', 'timeFrame': 'Between baseline (inpatient admission) and at 7 months follow-up', 'description': 'Change in: body weight (kg)'}, {'measure': 'Change in Body Mass Index', 'timeFrame': 'Between baseline (inpatient admission) and at 7 months follow-up', 'description': 'Change in Body Mass Index (BMI; kg/m2)'}, {'measure': 'Change in body fat mass', 'timeFrame': 'Between baseline (inpatient admission) and at 7 months follow-up', 'description': 'Change in body fat mass (kg)'}, {'measure': 'Change in body lean tissue mass', 'timeFrame': 'Between baseline (inpatient admission) and at 7 months follow-up', 'description': 'Change in body lean tissue mass (kg)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Body composition', 'Total body protein', 'nutritional recovery', 'Exercise status', 'In-vivo neutron activation analysis', 'Protein depletion'], 'conditions': ['Anorexia Nervosa']}, 'descriptionModule': {'briefSummary': 'The study aimed to assess protein accretion during weight gain in adolescent patients with Anorexia nervosa', 'detailedDescription': 'Background: Bone health and growth during adolescence require adequate Total Body Protein (TBPr). Re-nutrition for patients with anorexia nervosa (AN) should aim to normalize body composition, i.e. recovery of fat mass and TBPr.\n\nObjective: The study intended to analyze predictors of protein status, including exercise status, in adolescents with AN, and to investigate whether weight gain would replete body protein deficits.\n\nMethods: The investigators assessed TBPr in a longitudinal, observational study as height-adjusted nitrogen index (NI) using in-vivo neutron activation analysis in adolescents with AN at the commencement of refeeding (T0), as well as seven months thereafter (T1), and in age-matched normal weight controls. Lean tissue and fat mass were assessed with Dual-Energy X-Ray Absorptiometry (DXA). BMI, BMI-SDS and lean tissue mass were tested as predictors of protein status using Receiver Operating Characteristic (ROC) analysis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'At baseline assessment, ten patients had primary amenorrhea and 87 girls secondary amenorrhea. Six girls were not amenorrhoeic but were taking oral contraceptives or had lost more than 20% of their weight and fulfilled the remaining diagnostic criteria for AN. The mean duration of the eating disorder at the time of testing was 15 ± 12 months, ranging from 3 to 60 months and estimated premorbid BMI of the AN patients was 20.4 ± 2.9 (13.5 - 28.7 kg/m2; data available for 98 patients). Before admission, the patients (n = 97) had lost 15 ± 7 (2 - 36) kg. The mean weight on hospital admission (data available for 88 patients; 10 patients were outpatients; missing data, n = 5) was 41.1 ± 6.1 kg.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Patient Inclusion Criteria:\n\n* diagnosis of anorexia nervosa (DSM-IV)\n* aged 12 - 19 years\n* female gender\n\nPatient Exclusion Criteria:\n\n\\- existence of a further disease with effect on body composition\n\nControls:\n\n* no known disease\n* normal weight'}, 'identificationModule': {'nctId': 'NCT03334032', 'briefTitle': 'Incomplete Total Body Protein Recovery in Adolescent Patients With Anorexia Nervosa', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Incomplete Total Body Protein Recovery in Adolescent Patients With Anorexia Nervosa', 'orgStudyIdInfo': {'id': 'TBN in AN'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Inpatient treatment for Anorexia nervosa', 'description': 'Adolescents with anorexia nervosa assessed\n\n1. at baseline: on admission to inpatient treatment\n2. at follow-up: 6 months after admission on outpatient basis', 'interventionNames': ['Other: Inpatient treatment for Anorexia nervosa']}, {'label': 'Controls', 'description': 'Adolescent healthy and normal weight controls (matched for gender and age), assessed at one point of time'}], 'interventions': [{'name': 'Inpatient treatment for Anorexia nervosa', 'type': 'OTHER', 'description': 'Nutritional rehabilitation in a clinic with specialized eating disorder service', 'armGroupLabels': ['Inpatient treatment for Anorexia nervosa']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Michael R Kohn, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sydney'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Sydney', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator, Clinical Researcher', 'investigatorFullName': 'Dr. Verena Haas', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}