Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-26 @ 4:10 AM
Study NCT ID:
NCT01661127
Status:
UNKNOWN
Last Update Posted:
2014-11-04
First Post:
2012-08-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Study of PET/CT and Association With Metabolic Syndrome/Depressive Symptoms in Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'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': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Peripheral blood and 18-F-FDG PET/CT images'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-11-03', 'studyFirstSubmitDate': '2012-08-07', 'studyFirstSubmitQcDate': '2012-08-07', 'lastUpdatePostDateStruct': {'date': '2014-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Beck depression inventory scoring and Korean Hamilton depression scale scoring', 'timeFrame': 'Day 0 and 28 weeks later'}], 'secondaryOutcomes': [{'measure': 'Brain glucose uptake using PET/CT', 'timeFrame': 'Day 0 and 28 weeks later'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Psoriasis', 'Metabolic Syndrome', 'Depression']}, 'descriptionModule': {'briefSummary': 'Psoriasis is associated with increases in markers of inflammation in the skin and blood and increasingly is thought to be a systemic inflammatory disease and risk factor for incident diabetes mellitus, myocardial infarction, stroke, and premature cardiovascular death. Furthermore, it is important for clinicians to be aware that psoriasis can have a substantial emotional impact on an individual, which is not necessarily related to the extent of skin disease.\n\nFDG-PET/CT represents an innovative approach to studying systemic inflammation in a manner that is sensitive, quantifiable, and anatomically localizable. Also, recent study show that chronic disease such as end stage renal disease with depressive symptoms have decreased cerebral glucose metabolism in several brain areas in F-18-FDG PET/CT. So this protocol was designed to evaluate usefulness of PET/CT to detect systemic inflammation and abnormality of cerebral glucose metabolism and association with metabolic syndrome/major depressive symptoms in patients with psoriasis.', 'detailedDescription': '10 Patients with psoriasis\n\n1. Evaluate PASI score\n2. Evaluate comorbidity with metabolic syndrome\n\n * Body mass index(BMI)\n * Checking blood pressure\n * Checking blood sugar\n * Smoking and drinking history\n * Checking blood cholesterol level\n * Risk factors of cardiovascular disease\n3. PET/CT for measuring the extent and site of psoriasis with inflammation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients of diagnosed with psoriasis in Pusan National University Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological diagnosis of plaque type psoriasis\n* at least 18 years old\n\nExclusion Criteria:\n\n* those who cannot understand questionnaire\n* those who take antidepressant'}, 'identificationModule': {'nctId': 'NCT01661127', 'briefTitle': 'Clinical Study of PET/CT and Association With Metabolic Syndrome/Depressive Symptoms in Psoriasis', 'organization': {'class': 'OTHER', 'fullName': 'Pusan National University Hospital'}, 'officialTitle': 'Phase 0 Clinical Study of PET/CT and Association With Metabolic Syndrome/Depressive Symptoms in Psoriasis', 'orgStudyIdInfo': {'id': 'PNUHDM-psoriasis'}}, 'contactsLocationsModule': {'locations': [{'city': 'Busan', 'state': 'Busan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Byung-Soo Kim, Ph D.', 'role': 'CONTACT', 'email': 'dockbs@pusan.ac.kr', 'phone': '82-51-240-7338'}], 'facility': 'Department of dermatology, Pusan National University Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}], 'centralContacts': [{'name': 'Byung-Soo Kim, Ph D.', 'role': 'CONTACT', 'email': 'dockbs@pusan.ac.kr', 'phone': '82-51-240-7338'}], 'overallOfficials': [{'name': 'Byung-Soo Kim, Ph D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Pusan National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pusan National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}