Arteriosclerotic Cardiovascular Disease, Liraglutide, Type 2 Diabetes Mellitus
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Zhejiang Provincial People's Hospital
Zhejiang Provence Preventive Medicine Association
Ningbo Medical Center Lihuili Hospital
Affiliated Cixi Hospital of Wenzhou Medical University
Putuo People's Hospital
The Second People's Hospital of Yuhuan
Affiliated Wenling Hospital of Wenzhou Medical University
ShuGuang Hospital
Affiliated Hospital of Jiaxing University
Nanxun People's Hospital
The First People's Hospital of Huzhou
Lishui Hospital of TCM
Hangzhou hospital of Chinese Traditional Medicine
Zhejiang Greentown Cardiovascular Hospital
Red Cross Hospital, Hangzhou, China
The Second School of Medicine，WMU
The First People's Hospital of Xiaoshan
Zhejiang Hospital
Yiwu Central Hospital
Quzhou Hospital
Jinhua Hospital of TCM
Shaoxing Central Hospital
Shaoxinig Second Hospital
Huamei hospital, University of Chinese Academy of Sciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| New-onset cardiovascular events | maximum 2 years | Composite of angina pectoris, stroke, myocardial infarction, atherosclerotic plaque，unplanned rehospitalization, stent thrombosis, incidence of cardiac death in the duration of follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood glucose control | maximum 2 years | Change of fasting and postprandial blood glucose in the duration of follow-up |
| Lipid levels | maximum 2 years | Change of lipid levels（Total cholesterol, Total triglycerides, low density lipoprotein，high density lipoprotein） in the duration of follow-up |
| Blood pressure level | maximum 2 years | Change of blood pressure（mmHg） in the duration of follow-up |
| Body weight | maximum 2 years | Change of body weight(kg) in the duration of follow-up |
| Fat Distribution Indicators | maximum 2 years | Change of abdomen circumference（cm） in the duration of follow-up |
| Microvascular complications | maximum 2 years | Microvascular complications（such as Diabetic retinopathy，Diabetic nephropathy） in the duration of follow-up |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORXiaohong Wu, MD
Department of Endocriology, Zhejiang Provincial People's Hospital
Outcome results
None listed