Observational Study of ASCVD Risks of Type 2 Diabetes in East China
NCT ID: NCT04866667
Last Updated: 2021-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
800 participants
OBSERVATIONAL
2021-05-01
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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antidiabetic drugs including GLP-1 RAs
Apply Type 2 Diabetes mellitus patients with high risk of ASCVD with antidiabetic drugs including GLP-1 RAs
No interventions assigned to this group
antidiabetic drugs not including GLP-1 RAs
Apply Type 2 Diabetes mellitus patients with high risk of ASCVD with antidiabetic drugs not including GLP-1 RAs，such as metformin，insulin
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* HbA1c ≥7.0%
* Prior CVD cohort: age ≥50 and ≥1 of the following criteria.
* Prior MI
* Prior stroke or TIA
* Prior coronary, carotid or peripheral arterial revascularization
* N50% stenosis of coronary, carotid, or lower extremity arteries
* History of symptomatic CHD documented by Positive exercise stress test or any cardiac imaging or Unstable angina with ECG changes
* Asymptomatic cardiac ischemia Documented by positive nuclear imaging test, exercise test or dobutamine stress echo
* Chronic heart failure NYHA class II-III
* Chronic renal failure, eGFR \<60 mL/min per 1.73m2 MDRD eGFR \<60 mL/min per Cockcroft-Gault formula
* No Prior CVD group: Age ≥60 y and ≥1 of the following criteria.
* Microalbuminuria or proteinuria
* Hypertension and left ventricular hypertrophy by ECG or imaging
* Left ventricular systolic or diastolic dysfunction by imaging
* Ankle-brachial index b0.9
Exclusion Criteria
* other type diabetes
* Calcitonin ≥50 ng/L
* 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
* 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
* Acute decompensation of glycemic control
* An acute coronary or cerebrovascular event in the previous 14 d
* Currently planned coronary, carotid, or peripheral artery revascularization
* Chronic heart failure (NYHA class IV)
* Current continuous renal replacement therapy
* End-stage liver disease
* History of solid organ transplant or awaiting solid organ transplant
* Malignant neoplasm
* Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC)
* Personal history of non-familial medullary thyroid carcinoma
18 Years
ALL
No
Sponsors
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Zhejiang Provence Preventive Medicine Association
UNKNOWN
Ningbo Medical Center Lihuili Hospital
OTHER_GOV
Affiliated Cixi Hospital of Wenzhou Medical University
OTHER
Putuo People's Hospital
UNKNOWN
The Second People's Hospital of Yuhuan
UNKNOWN
Affiliated Wenling Hospital of Wenzhou Medical University
OTHER
ShuGuang Hospital
OTHER
Affiliated Hospital of Jiaxing University
OTHER
Nanxun People's Hospital
UNKNOWN
The First People's Hospital of Huzhou
OTHER
Lishui Hospital of TCM
UNKNOWN
Hangzhou hospital of Chinese Traditional Medicine
UNKNOWN
Zhejiang Greentown Cardiovascular Hospital
OTHER
Red Cross Hospital, Hangzhou, China
OTHER
The Second School of Medicine，WMU
UNKNOWN
The First People's Hospital of Xiaoshan
UNKNOWN
Zhejiang Hospital
OTHER
Yiwu Central Hospital
OTHER
Quzhou Hospital
UNKNOWN
Jinhua Hospital of TCM
UNKNOWN
Shaoxing Central Hospital
OTHER
Shaoxinig Second Hospital
UNKNOWN
Huamei hospital, University of Chinese Academy of Sciences
UNKNOWN
Zhejiang Provincial People's Hospital
OTHER
Responsible Party
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Xiao Ye, MD
Director Assistant
Principal Investigators
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Xiaohong Wu, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Endocriology, Zhejiang Provincial People's Hospital
Central Contacts
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Yu Lei, MD
Role: CONTACT
Phone: +86-571-85893937
Other Identifiers
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zjPPHNFM001
Identifier Type: -
Identifier Source: org_study_id