AzTrials
AzTrials

Metabolic Dysfunction-Associated Steatotic Liver DiseaseNCT07437157

The Establishment of Hong Kong Diabetes Steatotic Liver Disease Register

An observational study of Metabolic Dysfunction-Associated Steatotic Liver Disease and Type 2 Diabetes (T2DM), run by Chinese University of Hong Kong at 1 site in Hong Kong.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Liver is an important organ in maintaining energy homeostasis. Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), formerly known as non-alcoholic fatty liver disease (NAFLD), is the most common chronic liver disease locally and globally. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
How many people
1,000 participants
Where
1 siteHong Kong
Study dates
11 Jun 2025to 28 Feb 2027
How long will I take part?
15 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
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: People with T2DM and comorbid Steatotic Liver Disease

Who may be able to join

  • T2DM.
  • Aged ≥ 18 years.
  • Able and willing to give Informed written consent.

Who cannot join

  • Type 1 diabetes.
  • Terminal illness such as malignancy with limited life expectancy.
  • Any condition, as judged by the investigators, as ineligible to participate in this study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Alice Pik Shan Kong, MD contact

+852 3505 2648

alicekong@cuhk.edu.hk

Hong Kong1 site, 1 recruiting
  • Department of Medicine and Therapeutics, The Chinese University of Hong Kong (CUHK), Ward 3M, Diabetes and Endocrine Research Centre, 3/F Day Treatment Block and Children Wards (Old Block), Prince of Wales Hospital

    Hong Kong, New Territories, 99977

    Alice Pik Shan Kong, MD, +852 3505 2648, alicekong@cuhk.edu.hk

    Recruiting

Other trials in Hong Kong

About this study

Liver is an important organ in maintaining energy homeostasis. Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), formerly known as non-alcoholic fatty liver disease (NAFLD), is the most common chronic liver disease locally and globally. MASLD and type 2 diabetes mellitus (T2DM) are closely related with alarmingly high prevalence of MASLD in people with T2DM, along with the escalated risk of adverse clinical outcomes. Our group has reported that around 70% of people with T2DM have increased controlled attenuation parameter (CAP) suggestive of hepatic steatosis and one out of six had advanced liver fibrosis as evidenced by increased liver stiffness measurements (LSM). Despite its prevalence, close relationships and potential consequences, the mechanisms underlying the complex interconnections between MASLD and T2DM are not fully understood. MASLD is associated with a twofold higher risk of developing T2DM, independent of obesity and other common metabolic risk factors. This risk increases with the severity of MASLD, such that patients with more advanced stages of liver fibrosis are at a higher risk of developing T2DM. Moreover, the progression from hepatic steatosis to fibrosis is an important, yet not fully understood, step towards cirrhosis and end-stage liver disease. Identification of clinical predictors and biomarkers to select individuals with MAFLD for close monitoring is pivotal to prevent the sinister outcomes. To date, longitudinal cohorts with paired biobank focused on people with diabetes and comorbid MASLD for investigating the clinical courses and biomarkers for prediction of outcomes are lacking. We hypothesized that Hong Kong Chinese T2DM with comorbid steatotic liver disease have unique clinical courses and special biomarkers for predicting the progression to advanced liver fibrosis. The aims of this study are: 1) establish a prospective cohort of people with T2DM and comorbid steatotic liver disease accompanied with the setting up of a biobank; 2) elucidate the clinical courses and outcomes of Hong Kong Chinese T2DM with comorbid steatotic liver disease; 3) identify potential diagnostic markers of advanced liver fibrosis in people with T2DM and comorbid steatotic liver disease in Hong Kong. The primary outcome measure will be all-cause mortality and secondary outcome measure will be fatal and non-fatal CVD, heart failure, hospitalizations, NT-proBNP levels, and novel diagnostic markers of MASH in people with T2DM comorbid with MASLD.

Being tested
No intervention (observational study)
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.

  • No intervention (observational study)Other

    There is no intervention involved in this observational study.

Study groups in NCT07437157
Study groupRoleWhat they receive
SLDPatients with Type 2 Diabetes will be recruited for biomarkers and genetic markers, as well as Fibroscan will be performed.
Receives: Other: No intervention (observational study)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause mortality

    Death from any cause collected from hospital electronic medical record.

    Measured: 15 years

Secondary outcomes (5)
  1. Fatal and non-fatal cardiovascular disease

    Incidence of fatal and non-fatal cardiovascular disease collected from hospital electronic medical record

    Measured: 15 years

  2. Heart failure

    Incidence of heart failure collected from hospital electronic medical record

    Measured: 15 years

  3. Hospitalizations

    Incidence of hospitalizations collected from hospital electronic medical record

    Measured: 15 years

  4. NT-proBNP levels

    NT-proBNP levels collected from blood sample

    Measured: Baseline

  5. Novel diagnostic markers of Metabolic dysfunction-associated steatohepatitis related to bile acid metabolism

    Novel diagnostic markers of Metabolic dysfunction-associated steatohepatitis, related to bile acid metabolism, collected from blood sample.

    The novel biomarkers, cannot be disclosed in detail because the funding support is still pending (Project reference:T12-202/23-R). You can check on the website Theme-based Research Scheme (https://www.ugc.edu.hk/eng/rgc/funding_opport/trs/index.html) to enquire about what can be disclosed to the public.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2026
  2. Study start11 Jun 2025
  3. Primary completion28 Feb 2026 (estimated)
  4. Study completion28 Feb 2027 (estimated)

Resources

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
1,000 participants (estimated)
Target duration
15 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT07437157
Sponsor's protocol ID
CREC2025.119
Status last verified
Feb 2026
First submitted
22 Feb 2026
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Metabolic Dysfunction-Associated Steatotic Liver Disease and Type 2 Diabetes (T2DM), run by Chinese University of Hong Kong at 1 site in Hong Kong.

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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 27 Feb 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 Hong Kong. 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 Alice Pik Shan Kong, MD (+852 3505 2648, alicekong@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause mortality (time frame: 15 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 27 Feb 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in