Is a very low calorie diet an acceptable therapy to achieve a target weight loss in patients with advanced non-alcoholic fatty liver disease?

ewcastle upon Tyne Hospital NHS Trust0 个研究点目标入组 30 人开始时间: 2019年8月8日最近更新: 2023年9月18日

适应症

试验速览

2020 Results article in https://pubmed.ncbi.nlm.nih.gov/33094956/ (added 01/09/2021) 2020 Abstract results in https://pubmed.ncbi.nlm.nih.gov/32840677/ (added 06/09/2023) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34326098/ (added 06/09/2023)

•1. Adults aged 18-70 years
•2. NASH with = NIH NASH CRN stage 1 fibrosis confirmed on liver biopsy or a clinical diagnosis of NAFLD with imaging evidence of steatosis with a raised NAFLD fibrosis score [>-1.455]
•3. Weight stable (+/-3%) since biopsy/non-invasive assessment of liver
•4. BMI>27kg/m2
•5. Capacity to provide informed consent
•6. Ability to write and converse in English without the assistance of an interpreter

•1. Weight loss of >2kg in the past month
•2. Evidence of co-existent liver disease (e.g. autoimmune liver disease, viral hepatitis, alpha-1 anti-trypsin deficiency, haemochomatosis or Wilson’s disease)
•3. Current treatment with anti-obesity drugs
•4. Diagnosed/previous eating disorder or purging
•5. Excessive alcohol consumption (>21 units/week for males; >14 units/week for females)
•6. Insulin use
•7. Known cancer
•8. Myocardial infarction within 6 months
•9. Pregnant/considering pregnancy
•10. Previous hospital admission for depression or current antipsychotic drug medication
•11. Learning difficulties
•12. Decompensated NASH cirrhosis (Child Pugh score = 7)

发起方

ewcastle upon Tyne Hospital NHS Trust