NCT05899309

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 23, 2022

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 24, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 12, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

June 12, 2023

Status Verified

June 1, 2023

Enrollment Period

1.6 years

First QC Date

May 24, 2023

Last Update Submit

June 8, 2023

Conditions

Liver CirrhosisMetabolic SyndromeSpleen; FibrosisFrailty

Keywords

liver cirrhosisMetabolic syndromeCardiovascular events

Outcome Measures

Primary Outcomes (1)

  • Liver related events

    Determine the rate of liver related events with and without metabolic syndrome

    3 years

Secondary Outcomes (3)

  • Progression of cirrhosis

    3 years

  • Cardiovascular events

    3 years

  • Baseline cirrhosis features

    3 years

Study Arms (2)

Liver cirrhosis with metabolic syndrome

Liver cirrhosis patients with metabolic syndrome on standard treatment

Diagnostic Test: liver and spleen stiffness test and laboratory test

Liver cirrhosis without metabolic syndrome

Liver cirrhosis patients without metabolic syndrome on standard treatment

Diagnostic Test: liver and spleen stiffness test and laboratory test

Interventions

liver and spleen stiffness test and laboratory testDIAGNOSTIC_TEST

Diagnosis of cirrhosis can be based on liver biopsy,radiological ,clinical or liver stiffness measurement (LMS)

Liver cirrhosis with metabolic syndromeLiver cirrhosis without metabolic syndrome

Eligibility Criteria

Age21 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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.

You may qualify if:

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

You may not qualify if:

  • Terminal malignancy. Subjects with prognosis \< 3 months.
  • Patient refusal or unable to commit to study follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changi General Hospital

Singapore, 529889, Singapore

RECRUITING

Related Publications (2)

  • 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.

    PMID: 30983815BACKGROUND

  • 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.

    PMID: 26292950BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

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.

MeSH Terms

Conditions

Liver CirrhosisMetabolic SyndromeFibrosisFrailty

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Yu Jun Wong, MD

    Changi General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Siew Yoon Yap, BSc

CONTACT

68502935yap.siew.yoon@singhealth.com.sg

Seok Hwee Koo, PhD

CONTACT

68504929seok_hwee_koo@cgh.com.sg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2023

First Posted

June 12, 2023

Study Start

May 23, 2022

Primary Completion

December 12, 2023

Study Completion

September 1, 2024

Last Updated

June 12, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)