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The Influence of Ezetimibe on Gallbladder Function

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ClinicalTrials.gov Identifier: NCT00634140
Recruitment Status : Withdrawn (Study was never initiated due to lack of funding support.)
First Posted : March 12, 2008
Last Update Posted : March 30, 2015
Sponsor:
Information provided by:
Indiana University

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.


Condition or disease Intervention/treatment Phase
Chronic Acalculous Cholecystitis Drug: ezetimibe Drug: Placebo Not Applicable

Detailed Description:

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 cholecystitis and 3) to determine if ezetimibe normalizes gallbladder absorption/secretion modulators as well as gallbladder fat, cytokines and chemkines.

Subjects with typical biliary pain and or ejection fraction less than 30% on a HIDA scan will be identified. Patients will then be randomized with one group given ezetimibe and the other group given placebo. All subjects will have gallbladder ultrasound studies to determine volume before and after a standardized fatty meal both before starting ezetimibe or placebo and after 4 weeks. A cholecystectomy will then be performed. In addition, pieces of the gallbladder taken at cholecystectomy will be analyzed for ion flux, as well as absorption/secretion modulators and accumulation of toxic fats, metabolites, cytokines and chemokines.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Te Influence of Ezetimibe on Gallbladder Function
Study Start Date : August 2009
Estimated Primary Completion Date : August 2009
Estimated Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Ezetimibe

Arm Intervention/treatment
Experimental: 1
ezetimibe
Drug: ezetimibe
ezetimibe 10 mg daily for 4 to 6 weeks
Other Name: Zetia

Placebo Comparator: 2
placebo for 4-6 weeks
Drug: Placebo
placebo for 4-6 weeks




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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with typical biliary pain and ejection fraction <30% on a HIDA scan.
  • Must be > 18 years of age.

Exclusion Criteria:

  • Subjects with gallstones seen on HIDA.
  • Subjects on statin medication
  • Subjects with known allergies to ezetimibe.
  • Subjects who are pregnant or breast-feeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00634140


Locations
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United States, Indiana
Indiana University Hospital
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
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Principal Investigator: Henry A. Pitt, MD Indiana University
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Responsible Party: Henry A. Pitt, MD, Principal Investigator, Indiana University
ClinicalTrials.gov Identifier: NCT00634140    
Other Study ID Numbers: 0710-24
First Posted: March 12, 2008    Key Record Dates
Last Update Posted: March 30, 2015
Last Verified: March 2015
Keywords provided by Indiana University:
gallbladder
ezetimibe for 4 to 6 weeks prior to gallbladder removal
Additional relevant MeSH terms:
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Cholecystitis
Acalculous Cholecystitis
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents