Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2025-12-28 @ 6:34 AM
Study NCT ID:
NCT05575466
Status:
COMPLETED
Last Update Posted:
2024-10-15
First Post:
2022-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thromboembolism in Anorexia Nervosa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000856', 'term': 'Anorexia Nervosa'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D055677', 'term': 'Refeeding Syndrome'}], 'ancestors': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-10', 'studyFirstSubmitDate': '2022-10-05', 'studyFirstSubmitQcDate': '2022-10-10', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Hemostatic balance', 'timeFrame': 'The study is cross-sectional. Time frame for completion of participation in the study is 1 day.', 'description': 'Evaluation of differences of measurements of hemostatic biomarkers in patients with AN compared to healthy controls.\n\nHemostatic biomarkers that will be evaluated:\n\nTissue factor TF:Ag, pg/mL\n\nContact activation (descriptive, system is assessed)\n\nFibrinogen mg/dl\n\nThrombin generation (descriptive)\n\nProthrombin fragment 1+2 pmol/L\n\nPlasminogen activator inhibitor type 1 ng/mL\n\nTissue plasminogen activator ng/mL\n\nFibrin clot properties (descriptive, using turbidity measurements)'}, {'measure': 'Rotational Thromboelastometry (ROTEM)-variables', 'timeFrame': 'The study is cross-sectional. Time frame for completion of participation in the study is 1 day.', 'description': 'Evaluation of differences in ROTEM-variables in patients with AN compared to healthy controls.'}], 'primaryOutcomes': [{'measure': 'Incidence of thromboembolic events', 'timeFrame': 'Data on thromboembolic events are collected from health registries. Data is collected through study completion of the time frame in the registry, up to 26 years.', 'description': 'Arterial and venous thrombosis. Non-fatal outcomes of a thromboembolic event will be validated by the use of anticoagulants in the period immediately after the outcome defining event.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anorexia Nervosa', 'Thrombosis', 'Thromboembolism', 'Cortisol', 'Insulin', 'Nutrition', 'Refeeding Syndrome'], 'conditions': ['Anorexia Nervosa', 'Thrombosis', 'Thromboembolism']}, 'descriptionModule': {'briefSummary': 'BACKGROUND: Sudden death due to thromboembolic (TE) events in patients with anorexia nervosa (AN) is well known. However, the incidence of TE events and the hemostatic balance in patients with AN are sparsely investigated. Also, associations between re-nutrition and the hemostatic balance have not been studied.\n\nOBJECTIVE: To describe the incidence of TE events in patients with AN compared to the background population, to characterize the hemostatic balance in AN compared to normal-weight women, and to assess the associations between the hemostatic balance and nutritional status, insulin sensitivity and cortisol level in women with AN.\n\nMETHODS: The incidence of TE will be described using a Danish cohort of AN patients (n=10,049) with follow-up in national registries. A comprehensive battery of hemostatic biomarkers will be compared in a case-control study of 40 patients with AN and associations between hemostasis and nutritional status will be studied.', 'detailedDescription': 'BACKGROUND\n\nAnorexia nervosa (AN) is a complex psychiatric disorder with concomitant medical complications to malnutrition and starvation and it is associated with the highest mortality of the mental illnesses.\n\nIt is estimated that one-third of all deaths in patients with AN are due to cardiac causes, mainly sudden death, and alterations in cardiac electrical activity, structure and hemodynamics have been suggested as mortality causes. Thrombotic disorders such as myocardial infarction, stroke, and pulmonary embolism may also result in sudden cardiac death, and the investigators have previously reported venous thromboembolism in four patients with AN\n\nWhether a disturbed hemostatic balance is associated with re-nutrition, insulin sensitivity and cortisol in AN is unknown. The guidelines of thromboprophylaxis treatment may not be appropriate in this patient group due to metabolic and hemostatic disturbances and increased thrombotic risk of reasons related to refeeding syndrome not listed in current guidelines. To optimize guidelines for AN patients, new evidence is highly warranted\n\nAIMS\n\nThis study aims to determine the incidence of venous and arterial thromboembolic events in patients with AN compared to the background population, to characterize the hemostatic balance in AN compared to normal-weight women, and to assess the associations between the hemostatic balance and nutritional status, insulin sensitivity and cortisol level in women with AN. The study will provide new knowledge which qualifies the work of preparing guidelines for thrombosis prophylactic intervention in this patient group.\n\nRESEARCH QUESTIONS\n\n1. Is the incidence of venous and arterial thromboembolism increased in patients diagnosed with AN compared to an age-matched control group?\n2. Is the hemostatic balance disturbed in women with AN compared with healthy, normal-weight women?\n3. Are cortisol, insulin sensitivity and nutritional status associated with alterations in biomarkers of the hemostatic balance in AN?\n\nThe research questions will be answered in three sub studies.\n\nSUB STUDY 1\n\nSub study 1 will answer research question 1, determining if the incidence of venous and arterial thromboembolism is increased in patients with AN compared to an age-matched control group. The study is based on the comprehensive Danish registries. An already existing cohort of more than 10,000 patients with AN will be evaluated for incidence of thromboembolic events and compared to an age-matched control group.\n\nSUB STUDY 2\n\nSub study 2 will answer research question 2, exploring the hemostatic balance in patients with AN compared to healthy, normal-weight controls.\n\nPatients with anorexia nervosa (n=40) will be recruited from the highly specialized Center of Eating Disorders at Odense University Hospital. Patients and controls will have blood samples drawn to evaluate the hemostatic balance using a large battery of hemostatic markers.\n\nSUB STUDY 3\n\nSub study 3 will answer research question 3, clarifying associations between the hemostatic balance and cortisol, insulin sensitivity and nutritional status in AN. Participants of sub study 3 are the patients with AN from sub study 2. From further analysis of the blood samples and by answering validated questionnaires to determine nutritional status and AN severity, research question 3 will be answered.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with anorexia nervosa and healthy, age-matched controls.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria, patients:\n\n* Fulfilling Diagnostic and Statistical Manual V (DSM-5) criteria for AN\n* Age 18 - 50 years\n* Female sex\n\nExclusion Criteria, patients:\n\n* Somatic comorbidity requiring systemic medications\n* Previous thromboembolic event and/or known genetic predisposition\n* Use of p.o. hormonal contraception\n* Smoking\n\nInclusion Criteria, controls:\n\n* BMI 18.5 - 25.0\n* Age 18 - 50 years\n* Female sex\n\nExclusion Criteria, controls:\n\n* Somatic comorbidity requiring systemic medications\n* Previous thromboembolic event and/or known genetic predisposition\n* Use of p.o. hormonal contraception\n* Smoking'}, 'identificationModule': {'nctId': 'NCT05575466', 'acronym': 'TEAN', 'briefTitle': 'Thromboembolism in Anorexia Nervosa', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'Thromboembolism in Anorexia Nervosa: a Registry-based Study of a National Cohort and a Case-control Study of the Hemostatic Balance and Its Association with Nutritional Status, Insulin and Cortisol', 'orgStudyIdInfo': {'id': '85860'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'Will have thromboembolic incidence rate evaluated and will have a battery of hemostatic markers analyzed', 'interventionNames': ['Diagnostic Test: Blood samples', 'Diagnostic Test: Questionnaires']}, {'label': 'Controls', 'description': 'Will have thromboembolic incidence rate evaluated and will have a battery of hemostatic markers analyzed', 'interventionNames': ['Diagnostic Test: Blood samples']}], 'interventions': [{'name': 'Blood samples', 'type': 'DIAGNOSTIC_TEST', 'description': 'Hemostatic biomarkers', 'armGroupLabels': ['Controls', 'Patients']}, {'name': 'Questionnaires', 'type': 'DIAGNOSTIC_TEST', 'description': 'Eating Disorder Inventory - third version (EDI-3) Eating Disorder Quality of Life Scale (EDQLS)', 'armGroupLabels': ['Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Odense', 'state': 'Fyn', 'country': 'Denmark', 'facility': 'Clinical Pharmacology and Pharmacy, University of Southern Denmark', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'zip': '5000', 'city': 'Odense', 'state': 'Fyn', 'country': 'Denmark', 'facility': 'Department of Child and Adolescent Mental Health Odense, Mental Health Services in the Region of Southern Denmark', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'zip': '5220', 'city': 'Odense', 'state': 'Fyn', 'country': 'Denmark', 'facility': 'The Nutritional Unit, Department of Endocrinology, Center for Eating Disorders, Odense University Hospital and Psychiatry in the region of Southern Denmark', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'zip': '6700', 'city': 'Esbjerg', 'state': 'Jylland', 'country': 'Denmark', 'facility': 'Unit for Thrombosis Research, Department of Clinical Biochemistry, Hospital of South West Jutland', 'geoPoint': {'lat': 55.47028, 'lon': 8.45187}}, {'city': 'Umeå', 'state': 'Västerbotten County', 'country': 'Sweden', 'facility': 'Department of Clinical Sciences, Umeå University', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odense University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Jeanie Meincke Egedal, MD', 'investigatorAffiliation': 'Odense University Hospital'}}}}