Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT01382420
Status:
UNKNOWN
Last Update Posted:
2019-04-04
First Post:
2011-05-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long-term Beneficial Metabolic Effects of Adrenalectomy in Subclinical Cushing's Syndrome of Adrenal Incidentaloma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003480', 'term': 'Cushing Syndrome'}, {'id': 'C538238', 'term': 'Adrenal incidentaloma'}], 'ancestors': [{'id': 'D000308', 'term': 'Adrenocortical Hyperfunction'}, {'id': 'D000307', 'term': 'Adrenal Gland Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 234}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2024-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-03', 'studyFirstSubmitDate': '2011-05-30', 'studyFirstSubmitQcDate': '2011-06-23', 'lastUpdatePostDateStruct': {'date': '2019-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of lipid profile between two groups', 'timeFrame': '4 Year', 'description': 'lipid profile with LDL,apo B'}], 'secondaryOutcomes': [{'measure': 'Incidence of obesity between two groups', 'timeFrame': '4Year', 'description': 'measurement of body weight, height'}]}, 'conditionsModule': {'keywords': ['subclinical cushing syndrome', 'hypercortisolism', 'adrenal incidentaloma', 'adrenalectomy'], 'conditions': ['Cushing Syndrome']}, 'descriptionModule': {'briefSummary': "Objective:\n\nTo determine the metabolic effects of the adrenalectomy in subclinical Cushing's syndrome of adrenal incidentaloma.\n\nMethods:\n\n234 subclinical cushing syndrome and adrenal incidentaloma will be randomly assigned into two groups(e.g adrenalectomy group and conservative treatment group)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with both unilateral adrenal incidentaloma and hypercortisolism\n* definition of hypercortisolism\n\n * overnight dexamethasone suppression test, serum cortisol\\>1.8ug/dL\n * 24hr urine cortisol \\> upper reference limit\n\nExclusion Criteria:\n\n* patients who took medication influencing cortisol secretion\n* patients with definite clinical feature of cushing syndrome\n\n * moon face\n * abdominal striae\n * skin or proximal muscle atrophy\n* metabolic syndrome, hyperthyroidism, hyperparathyroidism, chronic renal failure, rheumatic disease, hematologic disease\n* patients who took following medication\n\n * insulin\n * oral hypoglycemic agent\n * thyroid hormone\n * anti-hyperlipidemic drug\n * sex hormone\n* patients who taking steroid hormone or who took steroid hormone more than 2 weeks within 1 year\n* psychiatric disease'}, 'identificationModule': {'nctId': 'NCT01382420', 'briefTitle': "Long-term Beneficial Metabolic Effects of Adrenalectomy in Subclinical Cushing's Syndrome of Adrenal Incidentaloma", 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': "Long-term Effects of Adrenalectomy on Metabolic Syndrome, Glucose Metabolism, Lipid Metabolism, and Bone Metabolism in Subclinical Cushing's Syndrome of Adrenal Incidentaloma", 'orgStudyIdInfo': {'id': '2011-03-034'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Adrenalectomy group', 'description': 'patients who undergo adrenalectomy', 'interventionNames': ['Procedure: surgery']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'patients who receive conservative treatment'}], 'interventions': [{'name': 'surgery', 'type': 'PROCEDURE', 'description': 'adrenalectomy', 'armGroupLabels': ['Adrenalectomy group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jae Hyeon Kim, M.D, Ph.D.', 'role': 'CONTACT', 'email': 'jaehyeonmd.kim@samsung.com', 'phone': '82-2-3410-1580'}, {'name': 'Seo Young Sohn', 'role': 'CONTACT', 'email': 'seoyoung.sohn@samsung.com', 'phone': '82-2-3410-1582'}], 'overallOfficials': [{'name': 'Jae Hyeon Kim', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Samsung Medical Center'}, {'name': 'Jung-Min Koh', 'role': 'STUDY_CHAIR', 'affiliation': 'M.D, Ph.D'}, {'name': 'Kee-Ho Song', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D, Ph.D.'}, {'name': 'Yumie Rhee', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D, Ph.D.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Asan Medical Center', 'class': 'OTHER'}, {'name': 'Severance Hospital', 'class': 'OTHER'}, {'name': 'Konkuk University Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jae Hyeon Kim', 'investigatorAffiliation': 'Samsung Medical Center'}}}}