Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05899309
Other study ID # 2021/2815
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT04635202 - Effect of Elliptical Training on Metabolic Homeostasis in Metabolic Syndrome N/A
Completed NCT04053686 - An Intervention to Reduce Prolonged Sitting in Police Staff N/A
Completed NCT05343858 - Pilot Study to Evaluate the Effect of Two Microalgae Consumption on Metabolic Syndrome N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Recruiting NCT05040958 - Carotid Atherosclerotic Plaque Load and Neck Circumference
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Active, not recruiting NCT02500147 - Metformin for Ectopic Fat Deposition and Metabolic Markers in Polycystic Ovary Syndrome (PCOS) Phase 4
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Completed NCT03289897 - Non-invasive Rapid Assessment of NAFLD Using Magnetic Resonance Imaging With LiverMultiScan N/A
Recruiting NCT05956886 - Sleep Chatbot Intervention for Emerging Black/African American Adults N/A
Completed NCT06057896 - Effects of Combined Natural Molecules on Metabolic Syndrome in Menopausal Women
Active, not recruiting NCT03613740 - Effect of Fucoxanthin on the Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion Phase 2
Completed NCT04498455 - Study of a Prebiotic Supplement to Mitigate Excessive Weight Gain Among Physicians in Residency Phase 4
Completed NCT05688917 - Green Coffee Effect on Metabolic Syndrome N/A
Completed NCT04117802 - Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome N/A
Completed NCT03697382 - Effect of Daily Steps on Fat Metabolism N/A
Completed NCT03241121 - Study of Eating Patterns With a Smartphone App and the Effects of Time Restricted Feeding in the Metabolic Syndrome N/A
Completed NCT04509206 - Virtual Teaching Kitchen N/A
Completed NCT05124847 - TREating Pediatric Obesity N/A