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Preventing decompensation is a key endpoint in the management of compensate cirrhosis patients. The known factors that increases the risk of decompensation include the presence of clinically significant portal hypertension (CSPH) and the control of primary etiology of cirrhosis. Other factors which may influence the progression of cirrhosis included the presence of metabolic syndrome (diabetes mellitus and obesity), frailty, concomitant medications (statin, non-selective beta-blocker) were not well understood. Investigators aim to perform a pilot, observational study to study various baseline factors in relation to the clinical outcome of cirrhosis patients in a prospective follow up.
All patient who fulfilled eligibility criteria will be consented and recruited. The study will last up to 3 years or up to 7 assessment and 7 visits All subjects will be followed every 6 monthly for study outcome from recruitment, biosamples (blood,urine and stool), elastography, quality of life questionnaire and frialty assessment were done at baseline. Completion of Sit to stand , handgrip and 6 minute walking test at baseline and Visit 3.All visits will be follow up on study outcome (liver-related events ,metabolic related outcome and cardiovascular related outcomes.). During decompensation (decrease in liver function ) .Collection of research leftover blood,urine and stool samples if applicable.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liver cirrhosis with metabolic syndrome | Liver cirrhosis patients with metabolic syndrome on standard treatment |
| |
| Liver cirrhosis without metabolic syndrome | Liver cirrhosis patients without metabolic syndrome on standard treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liver and spleen stiffness test and laboratory test | Diagnostic Test | Diagnosis of cirrhosis can be based on liver biopsy,radiological ,clinical or liver stiffness measurement (LMS) |
| Measure | Description | Time Frame |
|---|---|---|
| Liver related events | Determine the rate of liver related events with and without metabolic syndrome | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression of cirrhosis | To determine the proportion of patients with cirrhosis progression (stage as defined by D' Amico method). | 3 years |
| Cardiovascular events | Determine the rate of cardiovascular events with and without metabolic syndrome |
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Inclusion Criteria:
Exclusion Criteria:
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Personalize risk stratification in an unmet need because compensated cirrhosis patients has heterogeneous risk of deterioration.
With growing prevalence of obesity, there are more and more cirrhosis patients having metabolic syndrome. The impart of metabolic syndrome among cirrhosis patients remain unclear.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Siew Yoon Yap, BSc | Contact | 68502935 | yap.siew.yoon@singhealth.com.sg | |
| Seok Hwee Koo, PhD | Contact | 68504929 | seok_hwee_koo@cgh.com.sg |
| Name | Affiliation | Role |
|---|---|---|
| Yu Jun Wong, MD | Changi General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changi General Hospital | Recruiting | Singapore | 529889 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30983815 | Background | Harris PS, Hansen RM, Gray ME, Massoud OI, McGuire BM, Shoreibah MG. Hepatocellular carcinoma surveillance: An evidence-based approach. World J Gastroenterol. 2019 Apr 7;25(13):1550-1559. doi: 10.3748/wjg.v25.i13.1550. | |
| 26292950 | Background | Chang PE, Wong GW, Li JW, Lui HF, Chow WC, Tan CK. Epidemiology and Clinical Evolution of Liver Cirrhosis in Singapore. Ann Acad Med Singap. 2015 Jun;44(6):218-25. |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D024821 | Metabolic Syndrome |
| D005355 | Fibrosis |
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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6 mls of blood , 20 ml of urine and 1 gm of stool for research will be taken at Visit 1 and 3 . If there is decompensation 5 mls of blood will be obtain at each event.
| 3 years |
| Baseline cirrhosis features | Baseline differences (clinical, immunological and metabolomic differences) and liver stiffness and spleen stiffness measured using vibration on controlled transient elastography (in kPa) between cirrhosis patients with and without metabolic syndrome | 3 years |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |