The Establishment of Hong Kong Diabetes Steatotic Liver Disease Register

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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes (T2DM); Metabolic Dysfunction-Associated Steatotic Liver Disease
• Intervention / Treatment: Other: No intervention (observational study)

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Alice Pik Shan Kong, MD; Phone Number: +852 3505 2648; Email: alicekong@cuhk.edu.hk

Study Locations

• Hong Kong
  • New Territories
    • Hong Kong, New Territories, Hong Kong, 99977
      • 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
      • Contact: Alice Pik Shan Kong, MD; Phone Number: +852 3505 2648; Email: alicekong@cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

People with T2DM and comorbid Steatotic Liver Disease

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SLD; Patients with Type 2 Diabetes will be recruited for biomarkers and genetic markers, as well as Fibroscan will be performed.	Other: No intervention (observational study); There is no intervention involved in this observational study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	Death from any cause collected from hospital electronic medical record.	15 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatal and non-fatal cardiovascular disease	Incidence of fatal and non-fatal cardiovascular disease collected from hospital electronic medical record	15 years
Heart failure	Incidence of heart failure collected from hospital electronic medical record	15 years
Hospitalizations	Incidence of hospitalizations collected from hospital electronic medical record	15 years
NT-proBNP levels	NT-proBNP levels collected from blood sample	Baseline
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.	Baseline

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2025
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: February 22, 2026
• First Submitted That Met QC Criteria: February 22, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Investigative Techniques; Methods; Observation
• Other Study ID Numbers: CREC2025.119

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No