Cardiovascular Risk in T2DM With MAFLD: A Cohort Study (NCT07706010) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Cardiovascular Risk in T2DM With MAFLD: A Cohort Study
China7,000 participantsStarted 2026-07-12
Plain-language summary
This study aims to address the following key scientific question by establishing a large-scale, high-standard clinical cohort: the independent contribution of MASLD and its progression to liver fibrosis on cardiovascular outcomes in patients with T2DM, after excluding the confounding effects of traditional cardiovascular risk factors. Its technical value lies in utilizing prospective follow-up data combined with a multivariable competing risks model to develop and validate a cardiovascular risk prediction and early warning system tailored for Chinese populations with T2DM complicated by MASLD. Clinically, the findings will provide interdisciplinary evidence-based support for endocrinology and cardiology, helping clinicians identify high-risk individuals and prevent cardiovascular events through early intervention targeting hepatic metabolic disorders. This has significant implications for reducing overall mortality among diabetic patients in China and alleviating the public health burden.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
.Meet the diagnostic criteria for type 2 diabetes mellitus (T2DM) according to the Chinese Guideline for the Prevention and Treatment of Type 2 Diabetes (2022 edition), with a confirmed diagnosis for at least 3 months;
Exclusion criteria
.Willing to participate in this study and provide written informed consent;
.Able to cooperate with baseline survey and long-term follow-up (i.e., expected to reside in the study area during the follow-up period, without severe cognitive impairment, movement disorders, or other conditions that would interfere with follow-up).
.Concomitant severe cardiovascular or cerebrovascular disease, end-stage renal disease (CKD stage 5), malignant tumor, severe infection, etc., with an estimated life expectancy \<5 years;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Major Adverse Cardiovascular Events (MACE)
Timeframe: Baseline to 5 years
Trial details
NCT IDNCT07706010
SponsorThe Affiliated Hospital of Hangzhou Normal University
.Current use of medications that may significantly affect liver metabolism or glucose metabolism (other than routine glucose-lowering, lipid-regulating, or hepatoprotective agents) that cannot be adjusted;
.Pregnant or lactating women, or those planning to become pregnant in the near term;
.Severe mental illness or cognitive impairment that prevents cooperation with surveys and follow-up;
.Refusal to sign informed consent, or inability to comply with study procedures.