The Establishment of Hong Kong Diabetes Steatotic Liver Disease Register

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChinese University of Hong Kong

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

T2DM.

Aged ≥ 18 years.

Able and willing to give Informed written consent.

Disqualifiers

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 population

People with T2DM and comorbid Steatotic Liver Disease

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No intervention (observational study)

    Other intervention

    There is no intervention involved in this observational study.

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: SLD1 intervention

Trial outcomes

Primary outcomes

1

All-cause mortality

Death from any cause collected from hospital electronic medical record.

Time frame
15 years

Secondary outcomes

1

Fatal and non-fatal cardiovascular disease

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

Time frame
15 years
2

Heart failure

Incidence of heart failure collected from hospital electronic medical record

Time frame
15 years
3

Hospitalizations

Incidence of hospitalizations collected from hospital electronic medical record

Time frame
15 years
4

NT-proBNP levels

NT-proBNP levels collected from blood sample

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.