ISRCTN12900952已完成未知
Changes in liver fibrosis and inflammation estimated non-invasively after treatment with a low-energy total diet replacement programme in people with non-alcoholic steatohepatitis: a single-arm trial
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 16
研究概览
简要总结
2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37368513/ (added 27/07/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •BMI >=30 kg/m² and histological evidence of NASH and fibrosis stage 1a to 3
排除标准
- •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
研究者
相似试验
已完成
不适用
Determining the extent of liver scarring in patients with psoriasis using a non-invasive scan and assessing the relationship between liver scarring and other potential risk factors for liver damage including methotrexateiver fibrosis in psoriasisDigestive SystemFibrosis and cirrhosis of liverISRCTN15878562ewcastle upon Tyne Hospitals NHS Foundation Trust250
已完成
不适用
Impact of knowledge of liver fibrosis on drinking behaviourAlcohol misuseMental and Behavioural DisordersMental and behavioural disorders due to use of alcoholISRCTN16922410ottinghamshire Healthcare NHS Foundation Trust184
已完成
不适用
Evaluation of Frailty and Functional Capacity in End-Stage Liver DiseaseEnd Stage Liver DiseaseNCT04220723Hacettepe University40
招募中
不适用
Dynamic Changes and Risk Factors of Fibrosis and Steatosis Progression in Nonalcoholic Fatty Liver DiseaseNon-Alcoholic Fatty Liver DiseaseNCT03635541Beijing Friendship Hospital500
招募中
不适用
Analysis of liver fibrosis for chronic liver disease by the microbubble contrast agentsChronic liver diseaseJPRN-UMIN000015387Chiba University Graduate School of Medicine, Department of Gastroenterology and Nephrology120