Clinical Trial: The Influence of Ezetimibe on Gallbladder Function

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Te Influence of Ezetimibe on Gallbladder Function

Brief Summary:

Ezetimibe is a drug which inhibits the absorption of both dietary and biliary cholesterol in the small intestine. Ezetimibe has been approved for use in humans to lower serum cholesterol.

The primary aim of this study is to determine if ezetimibe normalizes resting and residual volume in patients with chronic acalculous cholecystitis.

Detailed Summary:

Gallbladder disease continues to be a major healthcare problem in the United States with more than 750,000 cholecystectomies being performed each year. In the last decade, the proportion of elective cholecystectomies performed for chronic acalculous cholecystitis has more than doubled. During this same time, obesity has reached epidemic proportions. In addition, obesity-induced visceral steatosis is known to cause a local inflammatory process resulting in organ dysfunction, with nonalcoholic steatohepatitis being a well established example of this phenomenon. Previous data from our lab also have shown that both congenital and diet-induced obesity result in cholecystosteatosis, an increase in gallbladder wall fats accompanied by altered gallbladder motility and absorption. This phenomenon also has been documented in humans, with patients with chronic acalculous and/or calculous cholecystitis having increased gallbladder fat than nondiseased controls.

Ezetimibe is a drug which inhibits the absorption of both dietary and biliary cholesterol in the small intestine. Ezetimibe has been approved for use in humans to lower serum cholesterol. Moreover, ezetimibe has been shown to ameliorate hepatic steatosis and cholesterol gallstone formation in animal models. Previous data from our lab have documented that ezetimibe lowers serum cholesterol, prevents biliary crystals and ameliorates cholecystosteatosis in lean mice fed a high fat diet. However, the influence of ezetimibe on gallbladder motility, absorption and accumulation of toxic fats, metabolites, cytokines and chemokines, cholecystosteatosis, have not been studied in humans. Therefore, the aims of this study are 1) to determine if ezetimibe normalizes resting and residual volume in patients with chronic acalculous cholecystitis, 2) to determine if ezetimibe normalizes gallbladder ion flux in patients with chronic acalculous
Sponsor: Indiana University

Current Primary Outcome: Normalization of resting gallbladder volume in patients with chronic acalculous cholecystitis [ Time Frame: Approximately 6 weeks after treatment ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Indiana University

Dates:
Date Received: March 3, 2008
Date Started: August 2009
Date Completion: August 2009
Last Updated: March 27, 2015
Last Verified: March 2015