Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2026-02-20 @ 1:46 AM
Study NCT ID:
NCT00627757
Status:
UNKNOWN
Last Update Posted:
2010-07-30
First Post:
2008-02-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antipsychotic Medicine and Metabolic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D015430', 'term': 'Weight Gain'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'whole blood, serum, plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-07-29', 'studyFirstSubmitDate': '2008-02-22', 'studyFirstSubmitQcDate': '2008-02-29', 'lastUpdatePostDateStruct': {'date': '2010-07-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['metabolic syndrome', 'weight gain', 'antipsychotic drugs', 'Metabolic syndrome and treatment with antipsychotic drugs'], 'conditions': ['Metabolic Syndrome']}, 'referencesModule': {'references': [{'pmid': '25295432', 'type': 'DERIVED', 'citation': 'Ebdrup BH, Knop FK, Madsen A, Mortensen HB, Sogaard B, Holst JJ, Szecsi PB, Lublin H. Glucometabolic hormones and cardiovascular risk markers in antipsychotic-treated patients. J Clin Psychiatry. 2014 Sep;75(9):e899-905. doi: 10.4088/JCP.13m08820.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine whether antipsychotic treatment is influence psychiatric patients due to endocrine and metabolic status and a quality of life.\n\nThe investigators expect, that 30-50% of patients will show pharmacon - gene induced weight gain (\\> 7% of initial bodyweight) while the rest of patients will maintain unaltered bodyweight.', 'detailedDescription': 'The primary aim of this study is to investigate status of neuro-and enteroendocrine axes with focus on beta - cell function in relation to insulin resistance, lipid profile abnormalities and inflammations adipokins in patients during treatment with antipsychotics (AP) in relation to weight gain.\n\nThe second aim is to evaluate the connection between weight gain and patients´ own perception of their quality of life and health.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '50 patients and 100 control persons. Patients should be treated with minimum one antipsychotic drug and hospitalized or treated as out-patients at Glostrup, Ballerup or Gentofte hospitals.\n\nControls will be chosen from the database at Institute of Health and Prevention, Glostrup.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* gender : male\n* age: 18-45\n* treatment with minimum one Antipsychotic drug (AP)\n* ethnicity: caucasians\n* consent given to take part in the project\n\nExclusion Criteria:\n\nOne criteria is sufficient to exclude patients from the study:\n\n* compliance problems\n* unable to read, write and talk Danish\n* patients with major lung-,heart-, lever- and kidney problems\n* patients with diagnose and treatment for Diabetes 1 and 2\n* patients taking cholesterol-reducing, weight-reducing and antihypertensive medication\n* patients with abuse of alcohol or drugs\n* patients who are under duress §\n* patients who have been mentally ill for more than 15 years\n* patients with diagnosis/treatment for NIDDM/IDDM'}, 'identificationModule': {'nctId': 'NCT00627757', 'acronym': 'AMMS1', 'briefTitle': 'Antipsychotic Medicine and Metabolic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Glostrup University Hospital, Copenhagen'}, 'officialTitle': 'Changes in Enteroendocrine and Neuroendocrine Axes in Patients With Weight Gain After Treatment With Antipsychotics', 'orgStudyIdInfo': {'id': 'HC-2007-0069'}, 'secondaryIdInfos': [{'id': '2602-706'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Food challenge test', 'description': 'Patients\n\n51 patients included'}, {'label': 'C', 'description': 'Controls 93 healthy controls are included'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2600', 'city': 'Copenhagen', 'state': 'Glostrup', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Henrik Lublin, MD DMSc', 'role': 'CONTACT', 'email': 'henlub01@glo.regionh.dk', 'phone': '045-43233540'}, {'name': 'Henrik Lublin, MD DMSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Psychiatric University Center Glostrup', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '2600', 'city': 'Copenhagen', 'state': 'Glostrup', 'status': 'NOT_YET_RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Henrik Lublin, MD DMSc', 'role': 'CONTACT', 'email': 'henlub01@glo.regionh.dk', 'phone': '045-43233540'}, {'name': 'Henrik Lublin, MD DMSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Psychiatric University Center Glostrup', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Henrik Lublin, MD DMSc', 'role': 'CONTACT', 'email': 'henlub01@glo.regionh.dk', 'phone': '045-43233540'}], 'overallOfficials': [{'name': 'Henrik Lublin, MD DMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Glostrup University Hospital, Copenhagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glostrup University Hospital, Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Gentofte, Copenhagen', 'class': 'OTHER'}, {'name': 'University of Copenhagen', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Henrik Lublin MD DMSc, Chairman and Associate Pofessor of Psychiatry', 'oldOrganization': 'Psychiatric University Center Glostrup Copenhagen University Hospitals'}}}}