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

NCT04866667 | Completed

• 1 other identifier: zjPPHNFM001
• Study Type: observational
• Target: 316
• Locations: 1 country
• Sites: 1

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.

Conditions

Liraglutide; Type 2 Diabetes Mellitus; Arteriosclerotic Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Blood glucose control

  maximum 2 years

• Lipid levels

  maximum 2 years

• Blood pressure level

  maximum 2 years

• Body weight

  maximum 2 years

• Fat Distribution Indicators

  maximum 2 years

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Zhejiang provincial people's hospital

Hangzhou, Zhejiang, 310014, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Xiaohong Wu, MD

  Department of Endocriology, Zhejiang Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Assistant

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: April 30, 2021
• Study Start: May 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: May 31, 2024
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)