TY - JOUR
T1 - Effect of bariatric surgery on NAFLD/NASH
T2 - a single-centre observational prospective cohort study
AU - Theel, Willy B.
AU - Boxma-De Klerk, Bianca M.
AU - Dirksmeier-Harinck, Femme
AU - Van Rossum, Elisabeth F.C.
AU - Kanhai, Danny A.
AU - Apers, Jan A.
AU - Van Dalen, Bas M.
AU - De Knegt, Robert J.
AU - Neecke, Bojou
AU - Van Der Zwan, Ellen M.
AU - Grobbee, Diederick E.
AU - Hankemeier, Thomas
AU - Wiebolt, Janneke
AU - Castro Cabezas, Manuel
N1 - Publisher Copyright:
© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2023/7/3
Y1 - 2023/7/3
N2 - Introduction The prevalence of non-alcoholic fatty liver disease (NAFLD) ranges from 25% in the general population to 90% in patients with obesity scheduled for bariatric surgery. NAFLD can progress towards non-alcoholic steatohepatitis (NASH) associated with complications such as cirrhosis, hepatocellular carcinoma and cardiovascular disease. To date, losing weight and lifestyle modifications are the best known treatments for NASH. Bariatric surgery significantly improves NAFLD/NASH in the short term. However, the extent of this improvement is not yet clear and long-term data on the natural course of NAFLD/NASH after bariatric surgery are lacking. The factors involved in NAFLD/NASH regression after bariatric surgery have not been elucidated. Methods and analysis This is an observational prospective cohort study including patients scheduled for bariatric surgery. Extensive metabolic and cardiovascular analyses will be carried out including measurements of carotid intima media thickness and pulse wave velocity. Genomic, proteomic, lipidomic and metabolomic studies will be done. Microbioma analyses before and 1 year after surgery will be done. Transient elastography measurements will be performed before and at 1, 3 and 5 years after surgery. For those with an elevated preoperative transient elastography measurement by Fibroscan, a laparoscopic liver biopsy will be performed during surgery. Primary outcome measures are the change of steatosis and liver fibrosis 5 years after surgery. Secondary outcome measure is the comparison of the transient elastography measurements with the NAFLD Activity Score from the biopsies. Ethics and dissemination The protocol has been approved by the Medical Research Ethics Committees United, Nieuwegein, on 1 March 2022 (registration code R21.103/NL79423.100.21). The study results will be submitted for publication in peer-reviewed journals and data will be presented at scientific meetings. Trial registration number NCT05499949.
AB - Introduction The prevalence of non-alcoholic fatty liver disease (NAFLD) ranges from 25% in the general population to 90% in patients with obesity scheduled for bariatric surgery. NAFLD can progress towards non-alcoholic steatohepatitis (NASH) associated with complications such as cirrhosis, hepatocellular carcinoma and cardiovascular disease. To date, losing weight and lifestyle modifications are the best known treatments for NASH. Bariatric surgery significantly improves NAFLD/NASH in the short term. However, the extent of this improvement is not yet clear and long-term data on the natural course of NAFLD/NASH after bariatric surgery are lacking. The factors involved in NAFLD/NASH regression after bariatric surgery have not been elucidated. Methods and analysis This is an observational prospective cohort study including patients scheduled for bariatric surgery. Extensive metabolic and cardiovascular analyses will be carried out including measurements of carotid intima media thickness and pulse wave velocity. Genomic, proteomic, lipidomic and metabolomic studies will be done. Microbioma analyses before and 1 year after surgery will be done. Transient elastography measurements will be performed before and at 1, 3 and 5 years after surgery. For those with an elevated preoperative transient elastography measurement by Fibroscan, a laparoscopic liver biopsy will be performed during surgery. Primary outcome measures are the change of steatosis and liver fibrosis 5 years after surgery. Secondary outcome measure is the comparison of the transient elastography measurements with the NAFLD Activity Score from the biopsies. Ethics and dissemination The protocol has been approved by the Medical Research Ethics Committees United, Nieuwegein, on 1 March 2022 (registration code R21.103/NL79423.100.21). The study results will be submitted for publication in peer-reviewed journals and data will be presented at scientific meetings. Trial registration number NCT05499949.
KW - EPIDEMIOLOGY
KW - Gastroenterology
KW - Hepatology
KW - Protocols & guidelines
UR - http://www.scopus.com/inward/record.url?scp=85163962375&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2022-070431
DO - 10.1136/bmjopen-2022-070431
M3 - Article
C2 - 37400234
AN - SCOPUS:85163962375
SN - 2044-6055
VL - 13
JO - BMJ Open
JF - BMJ Open
IS - 7
M1 - e070431
ER -