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

Not yet recruiting

• Conditions: Type 2 Diabetes Mellitus; Arteriosclerotic Cardiovascular Disease; Liraglutide

• Registration Number: NCT04866667
• Lead Sponsor: Zhejiang Provincial People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-04
• Study First Submitted: 2021-04-20
• Study First Submitted QC: 2021-04-29
• Last Update Submitted: 2021-04-29
• Study First Posted: 2021-04-30
• Last Update Posted: 2021-04-30
• Study Start: 2021-05-01
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 800

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Microvascular complications	maximum 2 years	Microvascular complications（such as Diabetic retinopathy，Diabetic nephropathy） 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 glucose control	maximum 2 years	Change of fasting and postprandial blood glucose 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 waist circumference（cm） in the duration of follow-up
Blood pressure level	maximum 2 years	Change of blood pressure（mmHg） in the duration of follow-up