Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2026-01-01 @ 9:07 PM
Study NCT ID:
NCT01060332
Status:
UNKNOWN
Last Update Posted:
2010-03-26
First Post:
2010-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Body Constitution and Quality of Life of Diabetic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2010-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-03-25', 'studyFirstSubmitDate': '2010-01-29', 'studyFirstSubmitQcDate': '2010-02-01', 'lastUpdatePostDateStruct': {'date': '2010-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body Constitution Questionnaire, BCQ', 'timeFrame': '1 month'}], 'secondaryOutcomes': [{'measure': 'Diabetes Impact Measurement Scales', 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'Diabetic Mellitus is the fifth cause of death by the report of Department of Health in 2008, and it often cause the severity of other chronic diseases. Neuropathy, retinopathy and renopathy are the most prevalent complications of DM, and they often influence the quality of life.\n\n300 patients with Diabetic neuropathy will be recruited in Taichung Veterans General Hospital endocrine and metabolism clinics. Body Constitution Questionnaire(BCQ), Diabetes Impact Measurement Scales(DIMS), Short Form -36(SF-36) will be asked to filled up, neurological examination (NE), AC sugar, HbA1c, lipid profiles, liver and kidney functions will be measured in order to evaluate the correlation between body constitution and quality of life on patients with diabetic complication.', 'detailedDescription': 'Diabetic Mellitus is the fifth cause of death by the report of Department of Health in 2008, and it often cause the severity of other chronic diseases. Neuropathy, retinopathy and renopathy are the most prevalent complications of DM, and they often influence the quality of life.\n\nTraditional Chinese Medicine was often prescribed to treat diabetic complications and improve the quality of life .But the study of objective evaluation of diagnostics of Traditional Chinese Medicine was few . It is important to analyze population of specific disease with well developed Traditional Chinese Medicine diagnostic tool with good validation and consistency.\n\n300 patients with Diabetic neuropathy will be recruited in Taichung Veterans General Hospital endocrine and metabolism clinics. Body Constitution Questionnaire(BCQ), Diabetes Impact Measurement Scales(DIMS), Short Form -36(SF-36) will be asked to filled up, neurological examination (NE), AC sugar, HbA1c, lipid profiles, liver and kidney functions will be measured in order to evaluate the correlation between body constitution and quality of life on patients with diabetic complication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Health Center for Diabetic Patient', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* There is a history of diabetes and the injection or taking hypoglycemic agents.\n* Aged 20 years of age, not limit to male or female .\n* Consciousness clear, subjects are willing to sign consent after stating research purpose and process.\n\nExclusion Criteria:\n\n* Took the Chinese medicine within the past month.'}, 'identificationModule': {'nctId': 'NCT01060332', 'briefTitle': 'The Body Constitution and Quality of Life of Diabetic', 'organization': {'class': 'OTHER', 'fullName': 'Taichung Veterans General Hospital'}, 'officialTitle': 'The Body Constitution and Quality of Life of Diabetic', 'orgStudyIdInfo': {'id': 'grb03484888'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'diabetics', 'interventionNames': ['Other: Body Constitution Questionnaire']}], 'interventions': [{'name': 'Body Constitution Questionnaire', 'type': 'OTHER', 'otherNames': ['BCQ'], 'description': 'Body Constitution Questionnaire was a tool for the study of objective evaluation of diagnostics of Traditional Chinese Medicine. It has been well developed with good validation and consistency.', 'armGroupLabels': ['diabetics']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40705', 'city': 'Taichung', 'state': 'Taiwan', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Chia-I Tsai, master', 'role': 'CONTACT', 'email': 'josepho777@yahoo.com.tw', 'phone': '886-4-23592525', 'phoneExt': '4755'}, {'name': 'Chia-I Tsai, master', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Taichung Veterans General Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'centralContacts': [{'name': 'Chia-I Tsai, master', 'role': 'CONTACT', 'email': 'josepho777@yahoo.com.tw', 'phone': '886-4-23592525', 'phoneExt': '4755'}], 'overallOfficials': [{'name': 'Jia-I Tsai, master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Traditional Chinese Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taichung Veterans General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Chia-I Tsai/Visiting Staff', 'oldOrganization': 'Traditional Chinese Medicine Department'}}}}