Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2026-03-13 @ 12:01 PM
Study NCT ID:
NCT03344718
Status:
COMPLETED
Last Update Posted:
2017-11-17
First Post:
2017-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolic Syndrome and Vitamin D Level in Old People
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D014808', 'term': 'Vitamin D Deficiency'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': "Centrifuged blood serum (5 ml) was stored in -80'C refrigerator for each subject."}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 549}, 'targetDuration': '6 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2012-08-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-13', 'studyFirstSubmitDate': '2017-09-10', 'studyFirstSubmitQcDate': '2017-11-13', 'lastUpdatePostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-08-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Osteoporotic fracture rate', 'timeFrame': '5 year', 'description': 'Vertebra, non-vertebra, major fracture'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Elderly', 'Metabolic Syndrome', 'Vitamin D Deficiency', 'Ostreocalcin', 'Insulin Resistance', 'Obesity', 'Osteoporosis', 'Sarcopenia']}, 'referencesModule': {'references': [{'pmid': '24450563', 'type': 'BACKGROUND', 'citation': 'Wu CH, Chen KT, Hou MT, Chang YF, Chang CS, Liu PY, Wu SJ, Chiu CJ, Jou IM, Chen CY. Prevalence and associated factors of sarcopenia and severe sarcopenia in older Taiwanese living in rural community: the Tianliao Old People study 04. Geriatr Gerontol Int. 2014 Feb;14 Suppl 1:69-75. doi: 10.1111/ggi.12233.'}]}, 'descriptionModule': {'briefSummary': 'In 2012, a cross-sectional survey sampling 1,966 community-dwelling old people was conducted. Structurized questionnaires were interviewed face-to-face by well-trained staffs. An overnight fasting blood were obtained for biochemistry parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Tianliao District, located in Kaohsiung City in southern Taiwan, is a tropical, agriculture-based community. It is located at around 22N50' latitude, like Hawaii (18° 55' N to 28° 27' N), and about 7° farther south than Florida (24° 27' N to 31° 00' N). The annual average temperature is 25.1°C (range: 19.3-29.2°C), and its annual average sunshine duration is 212.2 hours (longest: 221.4 hours in July; shortest: 161.8 hours in December). In the 2012 census report, the total population of Tianliao District was 7800, and 1966 (25.2%) participants were ≥ 65 years old.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* more than 65-year-old\n\nExclusion Criteria:\n\n* excluding empty houses, death, non-ambulatory subjects (subjects with significant disabilities, such as handicapped cerebral vascular accident, cancerous cachexia, unstable chronic diseases or psychiatric disorders, severe arthritis or inflammatory disease), uncomfortable anorexia by any medications, and non-reachable subjects'}, 'identificationModule': {'nctId': 'NCT03344718', 'briefTitle': 'Metabolic Syndrome and Vitamin D Level in Old People', 'organization': {'class': 'OTHER', 'fullName': 'National Cheng-Kung University Hospital'}, 'officialTitle': 'Inverse Relationship Between Metabolic Syndrome and Vitamin D Level in Old People Without Vitamin D Deficiency', 'orgStudyIdInfo': {'id': 'Tianliao old people study 2012'}}, 'contactsLocationsModule': {'locations': [{'city': 'Tainan', 'country': 'Taiwan', 'facility': 'Department of Family Medicine, National Cheng Kung Univ Hosp', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cheng-Kung University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}