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Completed

NCT Number: NCT04866667

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhejiang provincial people's hospital

Hangzhou, Zhejiang, 310014, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. New-onset cardiovascular events

    Time frame: 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 outcomes

  1. Blood glucose control

    Time frame: maximum 2 years

    Change of fasting and postprandial blood glucose in the duration of follow-up

  2. Lipid levels

    Time frame: maximum 2 years

    Change of lipid levels(Total cholesterol, Total triglycerides, low density lipoprotein,high density lipoprotein) in the duration of follow-up

  3. Blood pressure level

    Time frame: maximum 2 years

    Change of blood pressure(mmHg) in the duration of follow-up

  4. Body weight

    Time frame: maximum 2 years

    Change of body weight(kg) in the duration of follow-up

  5. Fat Distribution Indicators

    Time frame: maximum 2 years

    Change of abdomen circumference(cm) in the duration of follow-up

  6. Fat Distribution Indicators

    Time frame: maximum 2 years

    Change of waist circumference(cm) in the duration of follow-up

  7. Microvascular complications

    Time frame: maximum 2 years

    Microvascular complications(such as Diabetic retinopathy,Diabetic nephropathy) in the duration of follow-up

Sponsors and collaborators

Lead sponsor

Zhejiang Provincial People's Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Apr 30, 2021
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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