NCT04043585

Bariatric Surgery on NASH

Effects of Bariatric Surgery on Non-Alcoholic Steatohepatitis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 29 (actual)
• Sponsor: University Hospital, Gentofte, Copenhagen · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The study investigates non-alcoholic fatty liver disease from serial liver biopsies collected from participants referred for assessment of bariatric surgery, RYGB or SG.

Detailed description

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.

Conditions

• Non-Alcoholic Fatty Liver Disease
• Obesity

Timeline

• Start date: 2019-07-31
• Primary completion: 2023-03-29
• Completion: 2023-03-29
• First posted: 2019-08-02
• Last updated: 2023-11-29

Locations

1 site across 1 country: Denmark