An observational study in Non-Alcoholic Fatty Liver Disease and Obesity, sponsored by University Hospital, Gentofte, Copenhagen. Completed at 1 site in Denmark. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-29.
Sponsored by University Hospital, Gentofte, Copenhagen · Observational
The study investigates non-alcoholic fatty liver disease from serial liver biopsies collected from participants referred for assessment of bariatric surgery, RYGB or SG.
Non-alcoholic fatty liver disease (NAFLD) is an increasing health care problem closely related to obesity and has become the most common cause of chronic liver disease in developed countries. Today, bariatric surgery is the most efficient treatment of morbid obesity in terms of a rapid and sustained loss of weight. In addition, bariatric surgery is accompanied by improvement of weight-related comorbidities including features of the metabolic syndrome and possibly regression of the entire NAFLD spectrum.
The study is designed as an observational study including 40 patients referred to laparoscopic bariatric surgery (either RYGB or SG). The primary endpoint is change in NAFLD activity score (NAS) in serial liver biopsies collected from participants. Additional tests include blood samples, anthropometry measurements, Fibroscan and full body dual-energy X-ray absorptiometry (DEXA) scan performed together with each biopsy.
This unique model of serial liver biopsies in morbidly obese patients referred to bariatric surgery (RYGB or SG), combined with state-of-the-art technologies and bioinformatics, will provide important information about the effects of weight loss on NASH. The results will improve our understanding of the underlying mechanisms with the potential of identifying new potential NASH targets or diagnostic biomarkers.
1,507 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 303 are open to participants now.
This study's enrollment of 29 is below the median of 150 across 359 observational studies indexed under Non-alcoholic Fatty Liver Disease.
Browse Non-alcoholic Fatty Liver Disease studies →University Hospital, Gentofte, Copenhagen is the lead sponsor of 160 studies on the registry; 9 are open to participants now.
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30-40 patients referred to laparoscopic bariatric surgery (either RYGB or SG)
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Exclusion Criteria:
NAFLD activity score
Change in NAFLD activity score (NAS). Assessment of NAS, a standardized tool for assessment of liver histology, is often used for quantification of disease activity, allowing comparison of biopsies in clinical studies and improved reproducibility. The NAS is defined as the sum of scores for steatosis (0-3), lobular inflammation (0-3) and ballooning degeneration (0-2)
Time frame: 18 months
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Non-alcoholic Fatty Liver Disease →
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