Observational Study of ASCVD Risks of Type 2 Diabetes in East China

Study Overview
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Brief Summary
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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.

Official Title
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Screening and Intervention of Arteriosclerotic Cardiovascular Disease in Type 2 Diabetes in Zhejiang Province

Conditions
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Type 2 Diabetes Mellitus, Arteriosclerotic Cardiovascular Disease, Liraglutide

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes 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: Type 1 diabetes 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| antidiabetic drugs including GLP-1 RAs<br>Apply Type 2 Diabetes mellitus patients with high risk of ASCVD with antidiabetic drugs including GLP-1 RAs | |
| antidiabetic drugs not including GLP-1 RAs<br>Apply Type 2 Diabetes mellitus patients with high risk of ASCVD with antidiabetic drugs not including GLP-1 RAs，such as metformin，insulin | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New-onset cardiovascular events | Composite of angina pectoris, stroke, myocardial infarction, atherosclerotic plaque，unplanned rehospitalization, stent thrombosis, incidence of cardiac death in the duration of follow-up | maximum 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose control | Change of fasting and postprandial blood glucose in the duration of follow-up | maximum 2 years | 
| Lipid levels | Change of lipid levels（Total cholesterol, Total triglycerides, low density lipoprotein，high density lipoprotein） in the duration of follow-up | maximum 2 years | 
| Blood pressure level | Change of blood pressure（mmHg） in the duration of follow-up | maximum 2 years | 
| Body weight | Change of body weight(kg) in the duration of follow-up | maximum 2 years | 
| Fat Distribution Indicators | Change of abdomen circumference（cm） in the duration of follow-up | maximum 2 years | 
| Fat Distribution Indicators | Change of waist circumference（cm） in the duration of follow-up | maximum 2 years | 
| Microvascular complications | Microvascular complications（such as Diabetic retinopathy，Diabetic nephropathy） in the duration of follow-up | maximum 2 years |