The Establishment of Hong Kong Diabetes Steatotic Liver Disease Register

NCT07437157 | Recruiting

• 1 other identifier: CREC2025.119
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• All-cause mortality

  Death from any cause collected from hospital electronic medical record.

  15 years

Secondary Outcomes (5)

• Fatal and non-fatal cardiovascular disease

  15 years

• Heart failure

  15 years

• Hospitalizations

  15 years

• NT-proBNP levels

  Baseline

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

  Baseline

Study Arms (1)

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)

Interventions

No intervention (observational study) OTHER

There is no intervention involved in this observational study.

SLD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People with T2DM and comorbid Steatotic Liver Disease

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

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, Hong Kong

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Observation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Alice Pik Shan Kong, MD

CONTACT

+852 3505 2648; alicekong@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 22, 2026
• First Posted: February 27, 2026
• Study Start: June 11, 2025
• Primary Completion: February 28, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

HK (1)