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Cardiovascular Risk in T2DM With MAFLD: A Cohort Study

ConditionsType 2 Diabetes (T2DM)Metabolic Dysfunction-Associated Steatotic Liver Disease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe Affiliated Hospital of Hangzhou Normal University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1.Age ≥18 years, male or female;

Disqualifiers

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.;

Trial population

Adult patients (≥18 years) with type 2 diabetes mellitus and metabolic dysfunction-associated steatotic liver disease (MASLD) recruited from outpatient and inpatient departments of a tertiary hospital, who are able to complete long-term follow-up and provide informed consent.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

7,000 Participants
are grouped into 2 trial groups
Group A: T2DM with MASLD and Low Fibrosis Burden
Group B: T2DM with MASLD and Advanced Fibrosis

Trial outcomes

Primary outcomes

1

Major Adverse Cardiovascular Events (MACE)

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

Time frame
Baseline to 5 years

Secondary outcomes

1

Progression of Liver Fibrosis

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

Time frame
Every 12 months up to 5 years
2

All-cause Mortality

Death from any cause during follow-up.

Time frame
Baseline to 5 years
3

Renal Outcomes

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

Time frame
Time Frame: Baseline to 5 years
4

Cardiovascular Imaging Progression

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

Time frame
Annually for 5 years

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

MingWei Wang Status unavailable 310000, Hanzhou, ZhejiangChinaChina

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Affiliated Hospital of Hangzhou Normal University

Lead sponsor

Source ClinicalTrials.gov

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