Precision Medicine to Predict the Trajectory of Liver Cirrhosis: Prospective Cohort Study

Metabolic Syndrome Clinical Trial

Official title:

Precision Medicine to Predict the Trajectory of Liver Cirrhosis : Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05899309
• Other study ID #: 2021/2815
• Status: Recruiting
• Start date: May 23, 2022
• Est. completion date: September 2024

Study information

• Verified date: June 2023
• Source: Changi General Hospital
• Contact: Siew Yoon Yap, BSc
• Phone: 68502935
• Email: yap.siew.yoon[@]singhealth.com.sg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 2024
• Est. primary completion date: December 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

Inclusion Criteria:

• Aged 21 to 90 years with the diagnosis of liver cirrhosis (regardless of etiology)

• Consent to participate in the study

Exclusion Criteria:

• Terminal malignancy. Subjects with prognosis < 3 months.

• Patient refusal or unable to commit to study follow-up

Related Conditions & MeSH terms

• Fibrosis
• Frailty
• Liver Cirrhosis
• Metabolic Syndrome
• Spleen; Fibrosis

Intervention

Diagnostic Test:
• liver and spleen stiffness test and laboratory test
Diagnosis of cirrhosis can be based on liver biopsy,radiological ,clinical or liver stiffness measurement (LMS)

Locations

Country	Name	City	State
Singapore	Changi General Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Changi General Hospital

Country where clinical trial is conducted

Singapore, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver related events	Determine the rate of liver related events with and without metabolic syndrome	3 years
Secondary	Progression of cirrhosis	To determine the proportion of patients with cirrhosis progression (stage as defined by D' Amico method).	3 years
Secondary	Cardiovascular events	Determine the rate of cardiovascular events with and without metabolic syndrome	3 years
Secondary	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