Clinical trial NCT04866667: Observational Study of ASCVD Risks of Type 2 Diabetes in East China
Official title: Screening and Intervention of Arteriosclerotic Cardiovascular Disease in Type 2 Diabetes in Zhejiang Province
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 2 Diabetes Mellitus
Arteriosclerotic Cardiovascular Disease
Liraglutide
Lead sponsor: Zhejiang Provincial People's Hospital
Sponsor class: OTHER
Collaborators: name: Zhejiang Provence Preventive Medicine Association
name: Ningbo Medical Center Lihuili Hospital
name: Affiliated Cixi Hospital of Wenzhou Medical University
name: Putuo People's Hospital
name: The Second People's Hospital of Yuhuan
name: Affiliated Wenling Hospital of Wenzhou Medical University
name: ShuGuang Hospital
name: Affiliated Hospital of Jiaxing University
name: Nanxun People's Hospital
name: The First People's Hospital of Huzhou
name: Lishui Hospital of TCM
name: Hangzhou hospital of Chinese Traditional Medicine
name: Zhejiang Greentown Cardiovascular Hospital
name: Red Cross Hospital, Hangzhou, China
name: The Second School of Medicine，WMU
name: The First People's Hospital of Xiaoshan
name: Zhejiang Hospital
name: Yiwu Central Hospital
name: Quzhou Hospital
name: Jinhua Hospital of TCM
name: Shaoxing Central Hospital
name: Shaoxinig Second Hospital
name: Huamei hospital, University of Chinese Academy of Sciences
First posted: 2021-04-30
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 2 diabetes patients over 18 years old with high risks of atherosclerotic cardiovascular disease

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 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

Primary outcomes:
measure: New-onset cardiovascular events
timeFrame: maximum 2 years
Secondary outcomes:
measure: Blood glucose control
timeFrame: maximum 2 years
measure: Lipid levels
timeFrame: maximum 2 years
measure: Blood pressure level
timeFrame: maximum 2 years
measure: Body weight
timeFrame: maximum 2 years
measure: Fat Distribution Indicators
timeFrame: maximum 2 years
measure: Fat Distribution Indicators
timeFrame: maximum 2 years
measure: Microvascular complications
timeFrame: maximum 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Department of Endocriology, Zhejiang Provincial People's Hospital
name: Xiaohong Wu, MD
role: PRINCIPAL_INVESTIGATOR
References: