Monitoring Changes in Hepatic Steatosis Using Continuous Controlled Attenuation Parameter

NCT06203548 | Recruiting

• 1 other identifier: 2023.436
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Non-alcoholic fatty liver disease (NAFLD) affects 30% of the Asian adult population and is emerging as one of the important leading causes of liver cancer and cirrhosis. Although a number of biomarkersmany have been developed for the assessment of liver fat and fibrosis, most existing studies were cross-sectional in nature. The role of these biomarkers for monitoring and response assessment remains elusive. At present, magnetic resonance imaging proton density fat fraction (MRI-PDFF) is considered the gold standard to in quantifying liver fat. The MRI-PDFF response, defined as a ≥30% relative reduction in liver fat fraction, has been shown to correlate with improved hepatic inflammation and fibrosis. However, MRI is limited by cost and availability. The cContinuous controlled attenuation parameter (CAPc) measurement by vibration controlled transient elastography is a new technology to quantify liver fat. It is a point-of-care test and has the potential to replace the MRI-PDFF as a monitoring and response biomarker in routine practice. Study plan: This prospective cohort study will include 150 patients with NAFLD who will join a 6-month lifestyle modification programme involving dietary intervention and physical training. This will create a cohort of varying degrees of liver fat reduction. Using MRI-PDFF as the reference standard, we will evaluate the accuracy of a changes in CAPc in reflecting the MRI-PDFF response and remission of NAFLD, with all non-invasive tests performed at screening and Month 6. In addition, we will test the hypothesis that the the change in CAPc is superior to the change of in other steatosis tests results (including the original CAP, abdominal ultrasonography and steatosis scores of fatty liver index, hepatic steatosis index, NAFLD liver fat score and NAFLD ridge score) in predicting the MRI-PDFF response. The area under the receiver-operating characteristics curve of the CAPc response in predicting the MRI-PDFF response will be compared with that of the other steatosis tests using the DeLong test.

Conditions

Fatty Liver

Outcome Measures

Primary Outcomes (1)

• MRI-PDFF response

  \>30% relative reduction in MRI-PDFF

  6 months

Secondary Outcomes (1)

• Remission of MASLD

  6 months

Study Arms (1)

Metabolic dysfunction-associated steatotic liver disease

OTHER

Adult patients with intrahepatic triglyceride content \>=5% by MRI-PDFF

Behavioral: Lifestyle modification programme

Interventions

Lifestyle modification programme BEHAVIORAL

All patients will attend sessions weekly in the first 2 months and monthly in the remaining 4 months. The programme focuses on reducing caloric intake and increasing energy expenditure. At the first visit, the dietitian will perform a complete behavioural assessment including the patient's eating and lifestyle patterns, specific eating-related behaviours, knowledge, concerns and feelings. A target body weight will be set. During follow-up visits, the dietitian will review the patient's dietary pattern and provide recommendations. Each patient will be given an individualised meal plan. The dietary component and portion size are based on recommendations by the American Dietetic. The patients will be taught techniques to cope with at-risk situations such as parties and festival celebrations. In addition, the patients will be encouraged to have a combination of aerobic exercise and resistance training with intensity and frequency following the Physical Activity Guidelines.

Metabolic dysfunction-associated steatotic liver disease

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Intrahepatic triglyceride content by MRI-PDFF ≥5%
• At least one metabolic risk factor out of (1) body-mass index ≥23 kg/m2, (2) waist circumference ≥90 cm in men and ≥80 cm in women, (3) fasting plasma glucose ≥5.6 mmol/L, 2-hour post-load glucose ≥7.8 mmol/L, haemoglobin A1c (HbA1c) ≥5.7%, known diabetes or on treatment for type 2 diabetes, (4) blood pressure ≥130/85 mmHg or on treatment for hypertension, (5) plasma triglycerides ≥1.7 mmol/L or on treatment for dyslipidaemia, and (6) plasma high-density lipoprotein-cholesterol ≤1.0 mmol/L in men and ≤1.3 mmol/L in women or on treatment for dyslipidaemia
• Provide informed written consent

You may not qualify if:

• Positive hepatitis B surface antigen or anti-hepatitis C virus antibody, or history or evidence of other liver diseases
• Alcohol consumption \>30 g per day in men or \>20 g per day in women
• Liver decompensation, as evidenced by total bilirubin \>50 µmol/L (except in patients with documented Gilbert's syndrome), platelet count \<100 x 109/L, prothrombin time \>1.3 times the upper limit of normal, albumin \<35 g/L, or history or presence of ascites, varices or hepatic encephalopathy
• Contraindications to MRI examination such as claustrophobia or the presence of metallic implants
• History or presence of hepatocellular carcinoma
• History of other malignancies, unless in complete remission for more than 5 years
• History of liver transplantation or liver resection
• Significant co-morbidities that will likely limit a patient's participation in lifestyle intervention or attendance of study follow-ups

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, 0000, Hong Kong

RECRUITING

MeSH Terms

Conditions

Fatty Liver

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Central Study Contacts

Vincent Wong, MD

CONTACT

+85235054205; wongv@cuhk.edu.hk

Angel Chim, MSc

CONTACT

+85235054205; angelchim@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Lifestyle intervention programme

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 12, 2024
• Study Start: February 1, 2024
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)