ClinicaliQ Trial Snapshot
- Fructose is a Metabolic and Inflammatory Pathogenic Factor in Metabolic Dysfunction-associated Steatohepatitis (MASH) — Recruiting • Non-phase study • Oncology • NCT07013916.
- What is being tested: The role of fructose as a metabolic and inflammatory driver in MASH (metabolic dysfunction-associated steatohepatitis), investigating whether fructose specifically contributes to liver inflammation and damage progression beyond simple fat accumulation in MASLD.
- Patient eligibility overview: Adults with confirmed MASLD/MASH diagnosis, likely stratified by disease severity (presence of inflammation and fibrosis), excluding those with alternative causes of liver disease or significant comorbidities that would confound metabolic assessment.
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What This Trial Is Studying
MASLD (Metabolic dysfunction-associated steatotic liver disease) is a condition where fat builds up in the liver. It is the most common cause of liver disease worldwide. In some people, the fat can irritate the liver (inflammation) and cause damage. This is a more serious condition called MASH (Metabolic dysfunction-associated steatohepatitis). People with MASH more at risk of liver cirrhosis (advanced scarring in the liver) and liver cancer. It is not fully understood why MASLD becomes MASH, or why this happens in some people but not in others. However, it is…
Eligibility Snapshot
- : * Able and willing to give written informed consent * Age 45-65 at consent * HbA1c < 48 mmol/mol * Overweight and stage I obesity using BMI thresholds adjusted for ethnicity: * 23.0kg/m2 - 32.4kg/m2 in South Asian, Chinese, other Asian, Middle Eastern, Black African or African-Caribbean populations * 25kg/m2 - 34.9kg/m2 in White populations MASH Patients: Clinical diagnosis of MASH and F2 - F3 fibrosis: Either: Liver biopsy within 12 months of baseline Or: • History of histologically-diagnosed MASH with current evidence of fatty liver, AST>20 and Fibroscan CAP≥248 dB/m and stiffness 9.5kPa -14kPa Or: • FAST score >0.67 Patients with steatosis: • defined by Fibroscan CAP≥248dB/m and stiffness 21 units a week for males (participant-reported) * Smoking, vaping or use of nicotine-containing products within the last month * Taking prohibited medication: * Probiotic or antibiotic use within last 4 weeks (Note: participants will be considered eligible if they have undergone a 4-week washout from probiotics or 4-weeks after discontinuing antibiotic use) * any oral steroids within the last 6 weeks * current, or within 3 months, use of immunosuppressive medication * Amiodarone, nitrofurantoin, or anti-fungals within 3 months * Use of anti-obesity medication - orlistat or…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.