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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04866667
• Other study ID #: zjPPHNFM001
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Arteriosclerosis
• Arteriosclerotic Cardiovascular Disease
• Cardiovascular Diseases
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Liraglutide
• Type 2 Diabetes Mellitus

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