Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2026-01-02 @ 12:55 AM
Study NCT ID:
NCT00176150
Status:
UNKNOWN
Last Update Posted:
2005-09-15
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug Transport 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': 'OTHER', 'observationalModel': 'DEFINED_POPULATION'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2003-04', 'lastUpdateSubmitDate': '2005-09-13', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['anorexia nervosa', 'multidrug resistance', 'cholesterol metabolism'], 'conditions': ['Anorexia Nervosa']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate whether patients with anorexia nervosa have elevated plasma cholesterol levels and, if elevated plasma cholesterol levels influence drug transport by the ABC-transporter P-gp (P-glycoprotein, MDR 1/ABCB1). We will isolate peripheral blood mononuclear cells (PBMCs) and total RNA from the blood of patients with anorexia nervosa and healthy subjects as control. PBMCs will be used for quantitative cholesterol determination and for measuring the activity of P-gp using a FACS (fluorescence-activated cell sorting) method (rhodamine123 efflux). Total RNA will be used for quantitative expression analysis of P-gp by reverse transcriptase real time PCR.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '15 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\nDiagnosis anorexia nervosa according to DSM-IV (Diagnostic and Statistical Manual of Mental Disorders. Washington, DC) Refusal to gain weight to or over a minimal normal weight (BMI \\< 17,5 kg/m²) Fear of gaining weight despite underweight\n\nExclusion Criteria:\n\nContraindication for taking blood samples (haemoglobin \\< 8,5 g/dl) Medication which could influence the lipid metabolism (current and the last two months) Acute or chronic diseases, particularly malign diseases Diseases which could affect the safety of the patients or which could interfere with aims of the study Positive pregnancy test Excessive alcohol consumption (more than 30 g alcohol per day) or alcohol consumption within two days before sampling blood Disability to communicate with the investigator because of linguistic problems or because of a limited mental state\n\nInclusion criteria for healthy subjects:\n\nAge matched with patients with anorexia nervosa (18 years to 30 years) Well status of health Female Negative pregnancy test No clinical relevant diagnosis, particularly no hyperlipoproteinemias (LDL \\< 160 mg/dl) BMI \\> 18,0 kg/m² and \\< 25 kg/m²\n\nExclusion criteria for healthy subjects:\n\nMedication which could influence the lipid metabolism (current and two months ago inclusively) Acute or chronic diseases, particularly malign diseases Diseases which could affect the safety of the patients or which could interfere with aims of the study Positive pregnancy test Excessive alcohol consumption (more than 30 g alcohol per day) or alcohol consumption within two days before sampling blood Disability to communicate with the investigator because of linguistic problems or because of a limited mental state'}, 'identificationModule': {'nctId': 'NCT00176150', 'briefTitle': 'Drug Transport in Patients With Anorexia Nervosa', 'organization': {'class': 'OTHER', 'fullName': 'Heidelberg University'}, 'officialTitle': 'Influence of Cholesterol Plasma Levels on Drug Transport in Patients With Anorexia Nervosa', 'orgStudyIdInfo': {'id': 'K075'}}, 'contactsLocationsModule': {'locations': [{'zip': '69120', 'city': 'Heidelberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Caroline Storch', 'role': 'CONTACT', 'email': 'caroline.storch@med.uni-heidelberg.de', 'phone': '0049 6221 56 39939'}], 'facility': 'Department of Internal Medicine VI, Clinical Pharmacology and Pharmacoepidemiology', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'centralContacts': [{'name': 'Caroline Storch', 'role': 'CONTACT', 'email': 'caroline.storch@med.uni-heidelberg.de', 'phone': '0049 6221 56 39939'}], 'overallOfficials': [{'name': 'Walter Emil Haefeli, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Internal Medicine VI, Clinical Pharmacology and Pharmacoepidemilogy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heidelberg University', 'class': 'OTHER'}}}}