Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:48 PM
Study NCT ID:
NCT04866667
Status:
UNKNOWN
Last Update Posted:
2021-04-30
First Post:
2021-04-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Observational Study of ASCVD Risks of Type 2 Diabetes in East China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-29', 'studyFirstSubmitDate': '2021-04-20', 'studyFirstSubmitQcDate': '2021-04-29', 'lastUpdatePostDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'New-onset cardiovascular events', 'timeFrame': 'maximum 2 years', 'description': 'Composite of angina pectoris, stroke, myocardial infarction, atherosclerotic plaque，unplanned rehospitalization, stent thrombosis, incidence of cardiac death in the duration of follow-up'}], 'secondaryOutcomes': [{'measure': 'Blood glucose control', 'timeFrame': 'maximum 2 years', 'description': 'Change of fasting and postprandial blood glucose in the duration of follow-up'}, {'measure': 'Lipid levels', 'timeFrame': 'maximum 2 years', 'description': 'Change of lipid levels（Total cholesterol, Total triglycerides, low density lipoprotein，high density lipoprotein） in the duration of follow-up'}, {'measure': 'Blood pressure level', 'timeFrame': 'maximum 2 years', 'description': 'Change of blood pressure（mmHg） in the duration of follow-up'}, {'measure': 'Body weight', 'timeFrame': 'maximum 2 years', 'description': 'Change of body weight(kg) in the duration of follow-up'}, {'measure': 'Fat Distribution Indicators', 'timeFrame': 'maximum 2 years', 'description': 'Change of abdomen circumference（cm） in the duration of follow-up'}, {'measure': 'Fat Distribution Indicators', 'timeFrame': 'maximum 2 years', 'description': 'Change of waist circumference（cm） in the duration of follow-up'}, {'measure': 'Microvascular complications', 'timeFrame': 'maximum 2 years', 'description': 'Microvascular complications（such as Diabetic retinopathy，Diabetic nephropathy） in the duration of follow-up'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus', 'Arteriosclerotic Cardiovascular Disease', 'Liraglutide']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to screen patients with type 2 diabetes with high risk of cardiovascular disease, and intervene with or without Glucagon like peptide-1 receptor agonists.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Type 2 diabetes patients over 18 years old with high risks of atherosclerotic cardiovascular disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes\n* HbA1c ≥7.0%\n* Prior CVD cohort: age ≥50 and ≥1 of the following criteria.\n\n * Prior MI\n * Prior stroke or TIA\n * Prior coronary, carotid or peripheral arterial revascularization\n * N50% stenosis of coronary, carotid, or lower extremity arteries\n * History of symptomatic CHD documented by Positive exercise stress test or any cardiac imaging or Unstable angina with ECG changes\n * Asymptomatic cardiac ischemia Documented by positive nuclear imaging test, exercise test or dobutamine stress echo\n * Chronic heart failure NYHA class II-III\n * Chronic renal failure, eGFR \\<60 mL/min per 1.73m2 MDRD eGFR \\<60 mL/min per Cockcroft-Gault formula\n* No Prior CVD group: Age ≥60 y and ≥1 of the following criteria.\n\n * Microalbuminuria or proteinuria\n * Hypertension and left ventricular hypertrophy by ECG or imaging\n * Left ventricular systolic or diastolic dysfunction by imaging\n * Ankle-brachial index b0.9\n\nExclusion Criteria:\n\n* Type 1 diabetes\n* other type diabetes\n* Calcitonin ≥50 ng/L\n* Use of a GLP-1 receptor agonist (exenatide, liraglutide or other) or pramlintide or any DPP-4 inhibitor within the 3 months prior to screening\n* Use of insulin other than human NPH insulin or long-acting insulin analogue or premixed insulin within 3 months prior to screening. Shortterm use of other insulin during this period in connection with intercurrent illness is allowed, at Investigators discretion\n* Acute decompensation of glycemic control\n* An acute coronary or cerebrovascular event in the previous 14 d\n* Currently planned coronary, carotid, or peripheral artery revascularization\n* Chronic heart failure (NYHA class IV)\n* Current continuous renal replacement therapy\n* End-stage liver disease\n* History of solid organ transplant or awaiting solid organ transplant\n* Malignant neoplasm\n* Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC)\n* Personal history of non-familial medullary thyroid carcinoma'}, 'identificationModule': {'nctId': 'NCT04866667', 'briefTitle': 'Observational Study of ASCVD Risks of Type 2 Diabetes in East China', 'organization': {'class': 'OTHER', 'fullName': "Zhejiang Provincial People's Hospital"}, 'officialTitle': 'Screening and Intervention of Arteriosclerotic Cardiovascular Disease in Type 2 Diabetes in Zhejiang Province', 'orgStudyIdInfo': {'id': 'zjPPHNFM001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'antidiabetic drugs including GLP-1 RAs', 'description': 'Apply Type 2 Diabetes mellitus patients with high risk of ASCVD with antidiabetic drugs including GLP-1 RAs'}, {'label': 'antidiabetic drugs not including GLP-1 RAs', 'description': 'Apply Type 2 Diabetes mellitus patients with high risk of ASCVD with antidiabetic drugs not including GLP-1 RAs，such as metformin，insulin'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Xiao Ye, MD', 'role': 'CONTACT', 'email': 'semper_fi@foxmail.com', 'phone': '+86-571-85893937'}, {'name': 'Yu Lei, MD', 'role': 'CONTACT', 'phone': '+86-571-85893937'}], 'overallOfficials': [{'name': 'Xiaohong Wu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Department of Endocriology, Zhejiang Provincial People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan to share data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Zhejiang Provincial People's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Zhejiang Provence Preventive Medicine Association', 'class': 'UNKNOWN'}, {'name': 'Ningbo Medical Center Lihuili Hospital', 'class': 'OTHER_GOV'}, {'name': 'Affiliated Cixi Hospital of Wenzhou Medical University', 'class': 'OTHER'}, {'name': "Putuo People's Hospital", 'class': 'UNKNOWN'}, {'name': "The Second People's Hospital of Yuhuan", 'class': 'UNKNOWN'}, {'name': 'Affiliated Wenling Hospital of Wenzhou Medical University', 'class': 'OTHER'}, {'name': 'ShuGuang Hospital', 'class': 'OTHER'}, {'name': 'Affiliated Hospital of Jiaxing University', 'class': 'OTHER'}, {'name': "Nanxun People's Hospital", 'class': 'UNKNOWN'}, {'name': "The First People's Hospital of Huzhou", 'class': 'OTHER'}, {'name': 'Lishui Hospital of TCM', 'class': 'UNKNOWN'}, {'name': 'Hangzhou hospital of Chinese Traditional Medicine', 'class': 'UNKNOWN'}, {'name': 'Zhejiang Greentown Cardiovascular Hospital', 'class': 'OTHER'}, {'name': 'Red Cross Hospital, Hangzhou, China', 'class': 'OTHER'}, {'name': 'The Second School of Medicine，WMU', 'class': 'UNKNOWN'}, {'name': "The First People's Hospital of Xiaoshan", 'class': 'UNKNOWN'}, {'name': 'Zhejiang Hospital', 'class': 'OTHER'}, {'name': 'Yiwu Central Hospital', 'class': 'OTHER'}, {'name': 'Quzhou Hospital', 'class': 'UNKNOWN'}, {'name': 'Jinhua Hospital of TCM', 'class': 'UNKNOWN'}, {'name': 'Shaoxing Central Hospital', 'class': 'OTHER'}, {'name': 'Shaoxinig Second Hospital', 'class': 'UNKNOWN'}, {'name': 'Huamei hospital, University of Chinese Academy of Sciences', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director Assistant', 'investigatorFullName': 'Xiao Ye, MD', 'investigatorAffiliation': "Zhejiang Provincial People's Hospital"}}}}