Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-30 @ 2:17 PM
Study NCT ID:
NCT07016334
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-11
First Post:
2025-05-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
We Analyse Metabolites in Dried Blood Spots From Newborns That Later in Life Developed an Eating Disorder.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3000}, 'targetDuration': '44 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-03', 'studyFirstSubmitDate': '2025-05-21', 'studyFirstSubmitQcDate': '2025-06-03', 'lastUpdatePostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Metabolomic factors measured by mass-spectrometry', 'timeFrame': 'Sampled at birth (day 1)', 'description': 'Metabolomic factors such as amino acids, sugars, lipids, and organic acids extracted from dried blood spots sampled at birth are measured by mass spectrometry'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Eating Disorders']}, 'descriptionModule': {'briefSummary': 'Anorexia nervosa (AN) and bulimia nervosa (BN) are serious eating disorders (EDs) with significant morbidity and mortality. Genetic studies have shown associations between EDs and metabolic traits, and longitudinal studies indicate distinct weight trajectories in children who later develop AN or BN, suggesting early involvement of metabolic factors. Biological studies also reveal differences in immune and neurotrophic markers in individuals with EDs compared to controls. Intriguingly, metabolites measured in neonatal blood could serve as very early markers of ED risk, unconfounded by state or scar factors related to prolonged starvation.\n\nHere the investigators propose to comprehensively analyze neonatal biomarkers (metabolic, immune, and neurotrophic), epidemiological factors, and genetics to understand ED risk and develop risk prediction models'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Population born from 1981 with/or with out diagnosis of anorexia or bulimia nervosa', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- in PKU-register with or withou life-time diagnosis of anorexia or bulimi nervosa\n\nExclusion Criteria:\n\n* not in PKU register'}, 'identificationModule': {'nctId': 'NCT07016334', 'briefTitle': 'We Analyse Metabolites in Dried Blood Spots From Newborns That Later in Life Developed an Eating Disorder.', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'The Role of Metabolic, Immune, and Neurotrophic Markers in the Etiology of Eating Disorders Using Neonatal Bloodspots', 'orgStudyIdInfo': {'id': 'Analysis of blood spots in ED'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Anorexia nervosa', 'description': 'Diagnosed (life-time) with anorexia nervosa'}, {'label': 'Bulimia nervosa', 'description': 'Diagnosed (life-time) with bulimia nervosa'}, {'label': 'Controls', 'description': 'Never diagnosed with anorexia or bulimia nervosa'}]}, 'contactsLocationsModule': {'locations': [{'zip': '17176', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska Institutet', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ida AK Nilsson', 'investigatorAffiliation': 'Karolinska Institutet'}}}}