Type 2 Diabetes MellitusNCT04866667
Observational Study of ASCVD Risks of Type 2 Diabetes in East China
An observational study of Type 2 Diabetes Mellitus and Arteriosclerotic Cardiovascular Disease, run by Zhejiang Provincial People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus, Arteriosclerotic Cardiovascular Disease, Liraglutide
- How many people
- 316 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2021to 31 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Type 2 diabetes patients over 18 years old with high risks of atherosclerotic cardiovascular disease
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: maximum 2 years
Secondary outcomes (7)
Blood glucose control
Change of fasting and postprandial blood glucose in the duration of follow-up
Measured: 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
Measured: maximum 2 years
Blood pressure level
Change of blood pressure（mmHg） in the duration of follow-up
Measured: maximum 2 years
Body weight
Change of body weight(kg) in the duration of follow-up
Measured: maximum 2 years
Fat Distribution Indicators
Change of abdomen circumference（cm） in the duration of follow-up
Measured: maximum 2 years
Fat Distribution Indicators
Change of waist circumference（cm） in the duration of follow-up
Measured: maximum 2 years
Microvascular complications
Microvascular complications（such as Diabetic retinopathy，Diabetic nephropathy） in the duration of follow-up
Measured: maximum 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start1 May 2021
- Primary completion31 Dec 2023
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 316 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang Provence Preventive Medicine Association, Ningbo Medical Center Lihuili Hospital, Affiliated Cixi Hospital of Wenzhou Medical University, Putuo People's Hospital, The Second People's Hospital of Yuhuan, Affiliated Wenling Hospital of Wenzhou Medical University, ShuGuang Hospital, Affiliated Hospital of Jiaxing University, Nanxun People's Hospital, The First People's Hospital of Huzhou, The Fifth Affiliated Hospital of Wenzhou Medical University & Lishui Central Hospital, Hangzhou Hospital of Traditional Chinese Medicine, Zhejiang Greentown Cardiovascular Hospital, Red Cross Hospital, Hangzhou, China, The Second School of Medicine，WMU, The First People's Hospital of Xiaoshan, Zhejiang Hospital, Yiwu Central Hospital, Quzhou Hospital, Jinhua Hospital of TCM, Shaoxing Central Hospital, Shaoxinig Second Hospital, Chinese Academy of Sciences
- Responsible party
- Principal investigator, Xiao Ye, MD, Zhejiang Provincial People's Hospital
- Investigators
- Xiaohong Wu, MD, Principal investigator, Department of Endocriology, Zhejiang Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04866667
- Sponsor's protocol ID
- zjPPHNFM001
- Status last verified
- Apr 2026
- First submitted
- 20 Apr 2021
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share data
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening and Intervention of Arteriosclerotic Cardiovascular Disease in Type 2 Diabetes in Zhejiang Province
- ClinicalTrials.gov ID
- NCT04866667
- Acronym / sponsor ID
- zjPPHNFM001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 316 participants (actual)
- Lead sponsor
- Zhejiang Provincial People's HospitalUniversity, hospital or other
- Collaborators
- Zhejiang Provence Preventive Medicine Association, Ningbo Medical Center Lihuili Hospital, Affiliated Cixi Hospital of Wenzhou Medical University, Putuo People's Hospital, The Second People's Hospital of Yuhuan, Affiliated Wenling Hospital of Wenzhou Medical University, ShuGuang Hospital, Affiliated Hospital of Jiaxing University, Nanxun People's Hospital, The First People's Hospital of Huzhou, The Fifth Affiliated Hospital of Wenzhou Medical University & Lishui Central Hospital, Hangzhou Hospital of Traditional Chinese Medicine, Zhejiang Greentown Cardiovascular Hospital, Red Cross Hospital, Hangzhou, China, The Second School of Medicine，WMU, The First People's Hospital of Xiaoshan, Zhejiang Hospital, Yiwu Central Hospital, Quzhou Hospital, Jinhua Hospital of TCM, Shaoxing Central Hospital, Shaoxinig Second Hospital, Chinese Academy of Sciences
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 30 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type 2 diabetes patients over 18 years old with high risks of atherosclerotic cardiovascular disease
Key inclusion criteria (16 listed)
- Type 2 diabetes
- HbA1c ≥7.0%
- Prior CVD cohort: age ≥50 and ≥1 of the following criteria.
- No Prior CVD group: Age ≥60 y and ≥1 of the following criteria.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
7 secondary outcomes
Blood glucose control
Time frame: maximum 2 years
Lipid levels
Time frame: maximum 2 years
Blood pressure level
Time frame: maximum 2 years
Body weight
Time frame: maximum 2 years
Fat Distribution Indicators
Time frame: maximum 2 years
Fat Distribution Indicators
Time frame: maximum 2 years
Microvascular complications
Time frame: maximum 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No. No plan to share data
Related trials for Type 2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaohong Wu, MD principal investigator
Department of Endocriology, Zhejiang Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus and Arteriosclerotic Cardiovascular Disease, run by Zhejiang Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New-onset cardiovascular events (time frame: maximum 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.