1st Randomized Controlled Trial for Biopsy- Proven NASH Receives IRB Approval
May 2, 2019
The IRB has approved the first randomized controlled trial to compare lifestyle modification with and without Vertical sleeve gastrectomy (VSG) in adult patients with biopsy-proven NASH. This trial will not only evaluate the feasibility, safety, and efficacy of a large scale trial comparing these differing treatments but will also examine the impact of massive weight loss per se on improving NASH histology. Sayeed Ikramuddin, MD, MHA is the principal investigator.
Nonalcoholic fatty liver disease (NAFLD) is a chronic liver condition that impacts 83 million Americans and is characterized by fat (steatosis) of the liver. Twenty-five percent of individuals with NAFLD have associated inflammation and cellular damage in a condition known as nonalcoholic steatohepatitis (NASH). NASH is most common in people with type 2 diabetes and obesity and can result in fibrosis, cirrhosis, the need for liver transplant, and an increase in mortality. Weight loss is the only approved therapy for NASH.
Pre-screening is underway with enrollment anticipated to begin in June 2019.