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NCT Number: NCT07437157

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Location status: Recruiting

Location contact

Alice Pik Shan Kong, MD

CONTACT

[email protected]

+852 3505 2648

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention (observational study)

Other

There is no intervention involved in this observational study.

Primary outcomes

  1. All-cause mortality

    Time frame: 15 years

    Death from any cause collected from hospital electronic medical record.

Secondary outcomes

  1. Fatal and non-fatal cardiovascular disease

    Time frame: 15 years

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

  2. Heart failure

    Time frame: 15 years

    Incidence of heart failure collected from hospital electronic medical record

  3. Hospitalizations

    Time frame: 15 years

    Incidence of hospitalizations collected from hospital electronic medical record

  4. NT-proBNP levels

    Time frame: Baseline

    NT-proBNP levels collected from blood sample

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

    Time frame: Baseline

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alice Pik Shan Kong, MD

CONTACT

[email protected]

+852 3505 2648

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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