Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-03-02 @ 11:04 PM
Study NCT ID:
NCT03363360
Status:
UNKNOWN
Last Update Posted:
2017-12-06
First Post:
2017-11-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comprehensive Awareness and Control in Diabetes Patients in China Jiangxi: A Cross-Sectional Survey
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-11-30', 'studyFirstSubmitDate': '2017-11-30', 'studyFirstSubmitQcDate': '2017-11-30', 'lastUpdatePostDateStruct': {'date': '2017-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': 'The first 30 days or seven days after the visit', 'description': 'HbA1c \\<7%'}, {'measure': 'TC', 'timeFrame': 'The first 30 days or seven days after the visit', 'description': 'TC\\<5.2mmol/L'}, {'measure': 'TG', 'timeFrame': 'The first 30 days or seven days after the visit', 'description': 'TG\\<1.7mmol/L'}, {'measure': 'LDL-C', 'timeFrame': 'The first 30 days or seven days after the visit', 'description': 'LDL-C\\<3.3mmol/L'}, {'measure': 'HDL-C', 'timeFrame': 'The first 30 days or seven days after the visit', 'description': 'HDL-C\\>1.0mmol/L'}], 'secondaryOutcomes': [{'measure': 'blood pressure', 'timeFrame': 'On the day of the visit', 'description': 'systolic blood pressure \\<130 mm Hg, diastolic blood pressure \\<80 mm Hg'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['To Assess the Level of Control of Blood Glucose, Blood Pressure, and Blood Lipids Among Patients With Type 2 Diabetes in Jiangxi Province']}, 'descriptionModule': {'briefSummary': 'The study is a multicenter, sub-center contrast, cross-sectional survey.The primary objective of this study was to assess the Comprehensive Awareness and Control of blood glucose, blood pressure, and blood lipids among patients with type 2 diabetes in China Jiangxi. An additional objective was to investigate the impact of hospital type on clinical outcomes.', 'detailedDescription': "Background: With the continuous improvement of living standards in the past 30 years, the lifestyle and diet of Chinese people have undergone significant changes, leading to a significant increase in the prevalence of diabetes, hypertension and lipid metabolism disorders. Prevention and control work is also increasingly valued. At present, there is no research on the awareness rates and control rates of blood glucose, blood pressure and blood lipids in diabetic patients in Jiangxi Province. During the 13th Five-Year Plan period, the country has vigorously promoted the grading system of chronic non-communicable diseases, but there is a big gap between the levels of disease management in different levels of hospitals.\n\nMethods:The province's multi-center, sub-center control, cross-sectional survey, the number of cases planned to be included in 10000 cases. Patient Access: Within 2 years from the date of the study (December 2016), eligible patients were screened out of outpatients in the participating hospitals, and patients were reviewed and informed of the informed consent.Inclusion criteria: in line with the WHO1999 diabetes diagnostic criteria; age 20-80 years; duration of 1 year or more; signed informed consent. Exclusion criteria: at the same time using other experimental drugs or in other clinical trials; gestational diabetes, other special types of diabetes; in acute infection, trauma and other stress conditions and the acute phase of the disease and other anomalies; patients with malignant tumors."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '20 to 80 - year - old diabetic patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 20 years to 80 years who were diagnosed with diabetes according to the World Health Organization criteria, at least 1 years before screening,written informed consent\n\nExclusion Criteria:\n\n* Patients if they were pregnant or Other special types of diabetes, Patients with malignant tumor,participating in any other clinical studies, In phase of acute infection, trauma, such as stress state and acute phase of disease and other anomalies'}, 'identificationModule': {'nctId': 'NCT03363360', 'briefTitle': 'Comprehensive Awareness and Control in Diabetes Patients in China Jiangxi: A Cross-Sectional Survey', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital of Nanchang University'}, 'officialTitle': 'Comprehensive Awareness and Control in Diabetes Patients in China Jiangxi: A Cross-Sectional Survey', 'orgStudyIdInfo': {'id': 'DM20161201'}}, 'contactsLocationsModule': {'locations': [{'zip': '341000', 'city': 'Nanchang', 'state': 'Jiangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shen YenFeng, professor', 'role': 'CONTACT', 'email': '1359112481@qq.com', 'phone': '18970819455'}], 'facility': 'No.1MinDeRoad', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}], 'centralContacts': [{'name': 'Shen YunFeng, professor', 'role': 'CONTACT', 'email': '1359112481@qq.com', 'phone': '18970819455'}, {'name': 'Wang Jun', 'role': 'CONTACT', 'email': '1359112481@qq.com', 'phone': '15797727918'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Within 1 years of completion of the study', 'ipdSharing': 'YES', 'description': 'In the form of a paper published based on the results of the study', 'accessCriteria': 'Researchers who need the results of this study'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital of Nanchang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'YunFeng Shen', 'investigatorAffiliation': 'Second Affiliated Hospital of Nanchang University'}}}}