Status:
UNKNOWN
Observational Study of ASCVD Risks of Type 2 Diabetes in East China
Lead Sponsor:
Zhejiang Provincial People's Hospital
Collaborating Sponsors:
Zhejiang Provence Preventive Medicine Association
Ningbo Medical Center Lihuili Hospital
Conditions:
Type 2 Diabetes Mellitus
Arteriosclerotic Cardiovascular Disease
Eligibility:
All Genders
18+ years
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT04866667
Start Date
May 1 2021
End Date
December 31 2024
Last Update
April 30 2021
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