ISRCTN13053035已完成未知
Safety signals and potential efficacy of a low-energy total diet replacement programme with behavioural support to delay disease progression in compensated cirrhosis due to non-alcoholic fatty liver disease: a feasibility randomised controlled trial
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 17
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Participant is able to communicate in English and is willing and able to give informed consent for participation in the trial.
- •2. Aged =18 years.
- •3. BMI =30 kg/m² (or BMI =27.5 kg/m² for people of Black, Asian, or minority ethnic origin as per the NICE guidance for obesity screening)
- •4. Diagnosed with compensated cirrhosis due to non-alcoholic fatty liver disease based on one of the following:
- •4a. Biopsy with histological evidence of fibrosis score of 4 [with or without NASH (NASH defined as score of =1 for each of steatosis, inflammation, and ballooning] based on the NASH Clinical Research Network criteria
- •4b. Previous biopsy with evidence of NASH but with current non-histological diagnosis of cirrhosis*
- •4c. Previous biopsy or imaging with evidence of hepatic steatosis but with current nonhistological diagnosis of cirrhosis*
- •[*Definition of non-histological diagnosis of cirrhosis: Liver stiffness by transient elastography =15 kPA AND ANY of:
- •- imaging evidence of nodular OR irregular liver AND/OR
- •- presence of porto-systemic collateral vessels AND/OR
- •- splenomegaly (without alternative cause) AND/OR
- •- thrombocytopaenia in absence of primary haematological disease.]
- •5. Stable dose of medication(s) for type 2 diabetes for at least 3 months prior to screening visit.
- •6. Willing to allow his or her General Practitioner and consultant to be notified of participation in the trial.
排除标准
- •Current exclusion criteria as of 01/08/2023:
- •1. Evidence for any of the following alternative or co-existing aetiologies: alcohol [alcohol screening tool (AUDIT-C) score =8, and for patients for whom alcohol may have been a contributing factor to their diagnosis of cirrhosis, they will be excluded if they have any history of sustained harmful alcohol intake defined as =35 units for females and =50 units for males per week], active viral hepatitis (subjects cured for hepatitis C virus infection less than 2 years prior to screening are not eligible), haemochromatosis, primary biliary cholangitis, primary sclerosing cholangitis, Wilson disease, severe alpha-1-antitrypsin deficiency (ZZ phenotype), and autoimmune hepatitis .
- •2. Alcohol intake of =18 units for females and =26 units for males over the last 7 days, as per the NAFLD diagnostic criteria.
- •3. Platelet count <100 x 10(9) cells/l AND either medium (grade II) oesophageal or gastric varices with endoscopic high-risk stigmata (e.g., red signs), or large (grade III) varices on endoscopy within 1 year of screening [OR, IF NO ENDOSCOPY WITHIN 1 YEAR: exceeding the expanded Baveno VI criteria (platelet < 110 × 10(9) cells/L AND/OR stiffness >25 kPa)].
- •4. History or presence of hepatic decompensation (jaundice, ascites, hepatic encephalopathy, or variceal haemorrhage).
- •5. Model for end-stage liver disease (MELD) score = 13.
- •6. Child-Pugh score =8.
- •7. Total bilirubin >25.5 µmol/L (Note: Patients with documented Gilbert’s syndrome but conjugated bilirubin within normal range are eligible).
- •8. ALT =5x upper limit of normal.
- •9. AST =5x upper limit of normal.
- •10. INR >1.3.
- •11. HbA1c >11.3% (>100mmol/mol).
- •12. Listed for liver transplantation.
- •13. History of hepatocellular carcinoma or history of hepatocellular carcinoma treatment.
- •14. HIV infection.
- •15. Weight loss of 10% or more since diagnostic biopsy or, if biopsy not present, within the last 6 months.
- •16. Previous bariatric surgery or ileal resection.
- •17. History of biliary diversion.
- •18. Acute cholecystitis or acute biliary obstruction.
- •19. Contraindication to MRI.
- •20. Documented arrhythmia, except atrial fibrillation, or prolonged QT syndrome.
- •21. Taking warfarin.
- •22. Chronic renal failure of stage 4 or 5.
- •23. Scheduled for elective surgery under general anaesthesia.
- •24. Female participant who is pregnant, lactating, or planning pregnancy during the course of the trial.
- •25. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial.
- •26. Currently taking part in other interventional clinical trials unless approved by the CI.
- •27. Insulin use for more than 10 years for type 2 diabetes management AND C-peptide <600pmol/L.
- •28. Type 1 diabetes.
- •29. Evidence of proliferative retinopathy.
- •Previous exclusion criteria as of 20/10/2022:
- •1. Evidence for any of the following alternative or co-existing aetiologies: alcohol [alcohol screening tool (AUDIT-C) score = 8], active viral hepatitis (subjects cured for hepatitis C virus infection less than 2 years prior to screening are not eligible), haemochromatosis, primary biliary cholangitis, primary sclerosing cholangitis, Wilson disease, severe alpha-1-antitrypsin deficiency (ZZ phenotype), and autoimmune hepatitis.
- •2. Alcohol intake of =18 units for females and =26 units for males over the l
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