Cardiovascular Risk in T2DM With MAFLD: A Cohort Study

NCT07706010 | Not Yet Recruiting

• 1 other identifier: 2026（E2）-KS-077
• Study Type: observational
• Target: 7,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes (T2DM); Metabolic Dysfunction-Associated Steatotic Liver Disease

Outcome Measures

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

  Baseline to 5 years

Secondary Outcomes (5)

• Progression of Liver Fibrosis

  Every 12 months up to 5 years

• All-cause Mortality

  Baseline to 5 years

• Renal Outcomes

  Time Frame: Baseline to 5 years

• Cardiovascular Imaging Progression

  Annually for 5 years

• Liver-related Clinical Outcomes

  Baseline to 5 years

Study Arms (2)

T2DM with MASLD and Low Fibrosis Burden

Patients diagnosed with type 2 diabetes mellitus (T2DM) and metabolic dysfunction-associated steatotic liver disease (MASLD), with mild or no liver fibrosis (FIB-4 \<1.3 or liver stiffness measurement \[LSM\] \<8.0 kPa). Participants will receive routine clinical management and longitudinal follow-up.

T2DM with MASLD and Advanced Fibrosis

Patients diagnosed with T2DM and MASLD who have significant liver fibrosis (FIB-4 ≥1.3 or LSM ≥8.0 kPa). Participants will receive routine clinical management and longitudinal follow-up.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• Age ≥18 years, male or female;
• 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;
• 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).

You may not qualify if:

• 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.;
• 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;
• 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.

Sponsors & Collaborators

• The Affiliated Hospital of Hangzhou Normal University: lead

Study Sites (1)

MingWei Wang

Hanzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Mingwei W Wang, PhD

CONTACT

18758871517; wmw990556@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 15, 2026
• Study Start: July 12, 2026
• Primary Completion (Estimated): May 29, 2028
• Study Completion (Estimated): May 29, 2031
• Last Updated: July 15, 2026

Record last verified: 2026-06

Locations

CN (1)