Status:
NOT_YET_RECRUITING
Digital Diet and Exercise Intervention to Reduce Liver Fibrosis in Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)
Lead Sponsor:
St. George's Hospital, London
Conditions:
Metabolic Dysfunction-Associated Steatotic Liver Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Study Title: Digital Diet and Exercise Intervention to Reduce Liver Fibrosis in Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD): A Randomized Controlled Trial (D-FIB-MASLD) Objective...
Eligibility Criteria
Inclusion
- Adults 18 years and over
- Diagnosis of MASLD made by a hepatologist
- Vibration-Controlled Transient Elastography (VCTE) (FibroScan) liver stiffness measurement (LSM) 8 kPa and above
- Able to provide written consent
- Own a smartphone with data plan
Exclusion
- Alcohol consumption \>14 units/week
- BMI \>40
- Liver disease due to: Alcohol including MASLD with increased alcohol intake (MetALD), Any viral hepatitis, Autoimmune and cholestatic aetiologies including, but not limited to, primary biliary cholangitis and primary sclerosing cholangitis, Hereditary aetiologies including, but not limited to, haemachromatosis, Wilson's disease, alpha-1-antitrypsin deficiency
- Currently under investigation for cancer or receiving treatment for active cancer
- Myocardial infarction within last 6 months or uncontrolled cardiovascular disease
- Pregnant or planning
- Currently or due to be taking any of the following drugs: GLP-1/GIP agonists, Systemic high dose corticosteroids for \>6 weeks, Tamoxifen, Amiodarone, Methotrexate, Lomitapide, Valproate, Irinotecan, 5-Fluoruracil
- Currently using or enrolled in any other lifestyle intervention application or weight loss programme
- Undergone or due to undergo bariatric surgery including bariatric endoscopic procedures
- Any other intercurrent illness that is either life-threatening or of clinical significance such that it might limit compliance with study procedures, in the Investigator's opinion
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06920316
Start Date
May 1 2025
End Date
September 1 2027
Last Update
April 9 2025
Active Locations (1)
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1
St George's University Hospitals NHS Foundation Trust
London, London, United Kingdom, SW170QT