Fatty liver may be a hidden driver of heart attacks in diabetes
NCT ID NCT07706010
First seen Jul 15, 2026 · Last updated Jul 16, 2026 · Updated 1 time
Summary
This study follows 7,000 adults with type 2 diabetes and a common form of fatty liver disease (MASLD) to see how liver problems influence the risk of heart attacks, strokes, and heart failure. Researchers will track participants for five years, using advanced models to separate the liver's effect from other risk factors like high blood pressure or cholesterol. The goal is to build a heart-risk prediction tool tailored for Chinese patients with both conditions, helping doctors spot high-risk individuals earlier.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could lead to a better way to predict heart attacks and strokes in people with both type 2 diabetes and fatty liver disease, helping doctors intervene earlier.
- What could go wrong
- This is an observational study, not a treatment trial, so it cannot prove cause and effect. The findings may not apply to non-Chinese populations.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 7,000 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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May 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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MingWei Wang
Hanzhou, Zhejiang, 310000, China
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