iFT: Liver fibrosis after low-energy treatment in steatohepatitis

Not Applicable

Completed

• Conditions: onalcoholic steatohepatitis [NASH]; Digestive System; Nonalcoholic steatohepatitis [NASH]

• Registration Number: ISRCTN12900952
• Lead Sponsor: niversity of Oxford

Brief Summary

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37368513/ (added 27/07/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-14
• Study Completion: 2022-08-31
• Last Update Posted: 7 August 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

BMI >=30 kg/m² and histological evidence of NASH and fibrosis stage 1a to 3

Exclusion Criteria

1. ALT 10x upper limit of normal or above
2. Total bilirubin > 25.5 µmol/l
3. Evidence of other known forms of known chronic liver disease such as alcoholic liver disease, hepatitis B, hepatitis C, primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis, Wilson disease, iron overload, alpha-1-antitrypsin deficiency, drug-induced liver injury, known or suspected hepatocellular carcinoma (HCC)
4. Previous liver transplant or current placement on a liver transplant list
5. High risk of alcohol dependence defined as a score of 8 and above in the alcohol screening tool (AUDIT-C)
6. Consumption of more than 14 units of alcohol over the last week
7. Previous or planned bariatric surgery or ileal resection
8. History of biliary diversion
9. Acute cholecystitis or acute biliary obstruction
10. Contraindication to MRI
11. Currently attending or having attended within 3 months prior to study enrolment a weight management programme including behavioural programmes and weight loss medication
12. Weight loss of 5% or more since biopsy
13. Current insulin use
14. HbA1c > 9% (>75mmol/mol)
15. Diagnosed with type 2 diabetes with substantial changes in medication within the past 3 months
16. If taking GLP-1 agonists or SGLT2 inhibitors, changes in dosage during the past 6 months
17. Taking medication known to have potential activity against NASH (pioglitazone, Vitamin E)
18. Documented arrhythmia, except atrial fibrillation, or prolonged QT syndrome
19. Taking warfarin
20. Chronic renal failure of stage 4 or 5
21. Scheduled for surgery within 6 months
22. People having active treatment for cancer other than skin cancer treated with curative intent by local treatment only or people taking hormonal or other long-term secondary prevention treatment after initial cancer treatment
23. Currently taking part in other clinical trials
24. Pregnant, breastfeeding, or planning to become pregnant during the course of the study
25. Those that the clinician judges not able to meet the demands of either treatment programme or measurement schedule. This may include severe medical problems not listed above or severe psychiatric problems including substance misuse that make following the treatment programme or adhering to the protocol unlikely

Study & Design

• Study Type: Interventional
• Study Design: Not specified