Cardiovascular Risk in T2DM With MAFLD: A Cohort Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes (T2DM), Metabolic Dysfunction-Associated Steatotic Liver Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Cohort Study on Cardiovascular Risk in Type 2 Diabetes Mellitus Complicated With Metabolic Dysfunction-Associated Fatty Liver Disease
Overview
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.
Primary outcome measures
- Major Adverse Cardiovascular Events (MACE) [Time frame: Baseline to 5 years]
Secondary outcome measures (5)
- Progression of Liver Fibrosis [Time frame: Every 12 months up to 5 years]
- All-cause Mortality [Time frame: Baseline to 5 years]
- Renal Outcomes [Time frame: Time Frame: Baseline to 5 years]
- Cardiovascular Imaging Progression [Time frame: Annually for 5 years]
- Liver-related Clinical Outcomes [Time frame: Baseline to 5 years]
Eligibility criteria
Inclusion criteria
- 1.Age ≥18 years, male or female;
2.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;
3.Meet the diagnostic criteria for metabolic dysfunction-associated steatotic liver disease (MASLD) according to the \*Chinese Guideline for the Diagnosis and Treatment of Metabolic Dysfunction-Associated Steatotic Liver Disease (2024 edition)\*, with preliminary assessment including liver enzymes (ALT/AST), liver ultrasound, and non-invasive fibrosis markers (FIB-4, LSM), and exclusion of other liver diseases;
4.Willing to participate in this study and provide written informed consent;
5.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).
Exclusion criteria
- 1.Concomitant other chronic liver diseases: viral hepatitis (hepatitis B, hepatitis C, etc.), alcoholic liver disease (alcohol intake ≥140 g/week for males, ≥70 g/week for females), autoimmune liver disease, drug-induced liver injury, liver cirrhosis, liver cancer, etc.;
2.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;
3.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;
4.Pregnant or lactating women, or those planning to become pregnant in the near term;
5.Severe mental illness or cognitive impairment that prevents cooperation with surveys and follow-up;
6.Refusal to sign informed consent, or inability to comply with study procedures.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- MingWei Wang — Hanzhou
Identifiers
NCT: NCT07706010 · 2026（E2）-KS-077