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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04866667
Other study ID # zjPPHNFM001
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 1, 2021
Est. completion date December 31, 2024

Study information

Verified date April 2021
Source Zhejiang Provincial People's Hospital
Contact Xiao Ye, MD
Phone +86-571-85893937
Email semper_fi@foxmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 800
Est. completion date December 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (24)

Lead Sponsor Collaborator
Zhejiang Provincial People's Hospital Affiliated Cixi Hospital of Wenzhou Medical University, First People's Hospital Affiliated to Huzhou University, Hangzhou hospital of Chinese Traditional Medicine, Huamei hospital, University of Chinese Academy of Sciences, Jinhua Hospital of TCM, Lishui Hospital of TCM, Nanxun People's Hospital, Ningbo Medical Center Lihuili Hospital, Putuo People's Hospital, Quzhou Hospital, Red Cross Hospital of Hangzhou, Shaoxing Central Hospital, Shaoxinig Second Hospital, ShuGuang Hospital, The First People's Hospital of Jiaxing, The First People's Hospital of Xiaoshan, The Second People's Hospital of Yuhuan, The Second School of Medicine,WMU, Wenling People's Hospital, Yiwu Central Hospital, Zhejiang Greentown Cardiovascular Hospital, Zhejiang Provence Preventive Medicine Association, Zhejiang Xiaoshan hospital

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Blood glucose control Change of fasting and postprandial blood glucose in the duration of follow-up maximum 2 years
Secondary 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
Secondary Blood pressure level Change of blood pressure(mmHg) in the duration of follow-up maximum 2 years
Secondary Body weight Change of body weight(kg) in the duration of follow-up maximum 2 years
Secondary Fat Distribution Indicators Change of abdomen circumference(cm) in the duration of follow-up maximum 2 years
Secondary Fat Distribution Indicators Change of waist circumference(cm) in the duration of follow-up maximum 2 years
Secondary Microvascular complications Microvascular complications(such as Diabetic retinopathy,Diabetic nephropathy) in the duration of follow-up maximum 2 years
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