Type 2 Diabetes (T2DM)NCT07706010
Cardiovascular Risk in T2DM With MAFLD: A Cohort Study
An observational study of Type 2 Diabetes (T2DM) and Metabolic Dysfunction-Associated Steatotic Liver Disease, run by The Affiliated Hospital of Hangzhou Normal University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes (T2DM), Metabolic Dysfunction-Associated Steatotic Liver Disease
- How many people
- 7,000 participants
- Where
- 1 siteChina
- Study dates
- 12 Jul 2026to 29 May 2031
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
MingWei Wang
Hanzhou, Zhejiang, 310000
MingWei W Wang, PhD, 86-18758871517 ext. NOT, wmw990556@163.com
About this study
Official title: A Cohort Study on Cardiovascular Risk in Type 2 Diabetes Mellitus Complicated With Metabolic Dysfunction-Associated Fatty Liver Disease
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.
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to 5 years
Secondary outcomes (5)
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).
Measured: Every 12 months up to 5 years
All-cause Mortality
Death from any cause during follow-up.
Measured: Baseline to 5 years
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).
Measured: Time Frame: Baseline to 5 years
Cardiovascular Imaging Progression
Changes in carotid intima-media thickness (CIMT), carotid plaque burden, left ventricular structure and function, and coronary artery stenosis.
Measured: Annually for 5 years
Liver-related Clinical Outcomes
Development of cirrhosis, hepatocellular carcinoma, liver failure, or liver-related death.
Measured: Baseline to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start12 Jul 2026 (estimated)
- Primary completion29 May 2028 (estimated)
- Study completion29 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Hangzhou Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07706010
- Sponsor's protocol ID
- 2026（E2）-KS-077
- Status last verified
- Jun 2026
- First submitted
- 10 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study on Cardiovascular Risk in Type 2 Diabetes Mellitus Complicated With Metabolic Dysfunction-Associated Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT07706010
- Acronym / sponsor ID
- 2026（E2）-KS-077
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 7,000 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Hangzhou Normal UniversityUniversity, hospital or other
- Study start
- 12 Jul 2026 (estimated)
- Primary completion
- 29 May 2028 (estimated)
- Study completion
- 29 May 2031 (estimated)
- First posted
- 15 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes (T2DM) and Metabolic Dysfunction-Associated Steatotic Liver Disease, run by The Affiliated Hospital of Hangzhou Normal University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mingwei W Wang, PhD (18758871517 ext. not, wmw990556@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiovascular Events (MACE) (time frame: Baseline to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.