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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Type 2 Diabetes Mellitus; Liraglutide; Arteriosclerotic Cardiovascular Disease

• Study Type: Observational
• Enrollment (Anticipated): 800

Contacts and Locations

• Study Contact: Name: Xiao Ye, MD; Phone Number: +86-571-85893937; Email: semper_fi@foxmail.com
• Study Contact Backup: Name: Yu Lei, MD; Phone Number: +86-571-85893937

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Type 2 diabetes patients over 18 years old with high risks of atherosclerotic cardiovascular disease

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
antidiabetic drugs including GLP-1 RAs; 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; 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?

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

Collaborators and Investigators

• Sponsor: Zhejiang Provincial People's Hospital
• Collaborators: Ningbo Medical Center Lihuili Hospital; Red Cross Hospital, Hangzhou, China; The First People's Hospital of Huzhou; Yiwu Central Hospital; Shaoxing Central Hospital; ShuGuang Hospital; Huamei hospital, University of Chinese Academy of Sciences; First Affiliated Hospital of Jiaxing University; Zhejiang Hospital; Affiliated Cixi Hospital of Wenzhou Medical University; Zhejiang Greentown Cardiovascular Hospital; Zhejiang Provence Preventive Medicine Association; Putuo People's Hospital; The Second People's Hospital of Yuhuan; Wenling People's Hospital; Nanxun People's Hospital; Lishui Hospital of TCM; Hangzhou hospital of Chinese Traditional Medicine; The Second School of Medicine，WMU; The First People's Hospital of Xiaoshan; Quzhou Hospital; Jinhua Hospital of TCM; Shaoxinig Second Hospital
• Investigators: Principal Investigator: Xiaohong Wu, MD, Department of Endocriology, Zhejiang Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 1, 2021
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): December 31, 2024

Study Registration Dates

• First Submitted: April 20, 2021
• First Submitted That Met QC Criteria: April 29, 2021
• First Posted (ACTUAL): April 30, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 30, 2021
• Last Update Submitted That Met QC Criteria: April 29, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Arterial Occlusive Diseases; Endocrine System Diseases; Cardiovascular Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Arteriosclerosis
• Other Study ID Numbers: zjPPHNFM001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No