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NCT Number: NCT07706010

Cardiovascular Risk in T2DM With MAFLD: A Cohort Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Major Adverse Cardiovascular Events (MACE)

    Time frame: Baseline to 5 years

    The occurrence of major adverse cardiovascular events during the 5-year follow-up period, including:

    Cardiovascular death Non-fatal myocardial infarction Non-fatal ischemic or hemorrhagic stroke Hospitalization for heart failure

Secondary outcomes

  1. Progression of Liver Fibrosis

    Time frame: Every 12 months up to 5 years

    Changes in liver fibrosis severity assessed by liver stiffness measurement (LSM), Fibrosis-4 index (FIB-4), and controlled attenuation parameter (CAP).

  2. All-cause Mortality

    Time frame: Baseline to 5 years

    Death from any cause during follow-up.

  3. Renal Outcomes

    Time frame: Time Frame: Baseline to 5 years

    Development of end-stage kidney disease (ESKD), decline in estimated glomerular filtration rate (eGFR), or significant increase in urinary albumin-to-creatinine ratio (UACR).

  4. Cardiovascular Imaging Progression

    Time frame: Annually for 5 years

    Changes in carotid intima-media thickness (CIMT), carotid plaque burden, left ventricular structure and function, and coronary artery stenosis.

  5. Liver-related Clinical Outcomes

    Time frame: Baseline to 5 years

    Development of cirrhosis, hepatocellular carcinoma, liver failure, or liver-related death.

Study contacts

Contact information is provided by the study sponsor or research team.

Mingwei W Wang, PhD

CONTACT

[email protected]

18758871517 ext. not

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital of Hangzhou Normal University

Other

Registry information

Official study title

A Cohort Study on Cardiovascular Risk in Type 2 Diabetes Mellitus Complicated With Metabolic Dysfunction-Associated Fatty Liver Disease

Important dates

Study start
2026
Primary completion
2028
Study completion
2031
First posted
Jul 15, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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