Working... Menu

Development of a Breath Test for Monitoring Patients With Liver Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00244569
Recruitment Status : Completed
First Posted : October 26, 2005
Last Update Posted : March 20, 2017
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief Summary:
The purpose of this study is to determine the safety and efficacy of the Oridion Breath ID machine in monitoring liver metabolic functions.

Condition or disease Intervention/treatment Phase
Fatty Liver Cirrhosis Drug: 13C-Methacetin Device: Breath ID Machine Phase 3

Detailed Description:

Percutaneous liver biopsy has been utilized for decades to assess the severity of chronic liver disease, regardless of etiology. During this procedure a core sample of liver is obtained and examined histologically for the presence of inflammation, fibrosis and other features characteristic of specific liver disorders.Although liver biopsy is the gold standard by which to assess liver disease severity the procedure has significant limitations. Liver biopsy is a costly, invasive procedure with risks for morbidity and mortality. In addition, liver biopsy and examination of liver histology is subject to sampling variation and the manner by which these findings are evaluated and reported by individual pathologists.

Because of these limitations several investigators have attempted to develop alternative methods by which to assess liver disease severity. One approach was the development of serum markers which can estimate liver fibrosis. Such tests were developed by analyzing a battery of serum liver chemistries and the platelet count. Unfortunately, the test cannot detect more subtle changes in liver fibrosis and does not provide any information regarding hepatic function in patients with established cirrhosis. The concept of a metabolic liver function test, which could be utilized to assess the liver function was first explored several decades ago (20). Such tests are performed by administering a compound either orally or intravenously. The compound is removed by the liver from the blood, metabolized and a metabolic product is released back into the blood and excreted in the urine, saliva or exhaled breath; or the metabolic product is excreted in bile. Measuring the amount of the administered product that remains in serum over time or the amount of metabolic product which is produced and/or the rate at which this product is excreted provides an accurate measure of hepatic metabolic function.

Breath testing utilizing 13C labeled substrates provides a safe, non-invasive means for measuring hepatic metabolism. 13C is a stable, non-radioactive isotope which can be incorporated into a specific location within a test substrate so that it would be released when the compound is metabolized by the liver. Ideally, the 13C-compound would be administered orally, rapidly absorbed, metabolized by the liver and 13CO2 would be measured in exhaled breath within 20-30 minutes. Hepatic metabolism of the compound would be assessed by measuring the ratio of 13C/12C in exhaled breath. The ability to detect, differentiate and quantify 13C and 12C in exhaled CO2 has been greatly facilitated by the recent development of the Breath ID® collection system and analyzer unit. This portable device continuously senses exhaled breath and analyzes CO2 in real-time through a nasal cannula worn by the patient.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Development of a Breath Test for Monitoring Liver Metabolic Function in Patients With Chronic Liver Disease and Cirrhosis
Study Start Date : September 2005
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

Primary Outcome Measures :
  1. The mean and standards of results obtained from the Breath ID system for each of the 3 groups of patients with nonalcoholic fatty liver disease/nonalcoholic steatohepatitis (NAFLD/NASH) will be compared by chi squared analysis.
  2. A p value of 0.05 or less will be considered significant.

Secondary Outcome Measures :
  1. Receiver-operator curves will be developed to compare the results of the Breath ID to each histologic group of patients studied. A p value of 0.05 will be considered significant.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult men and women (age 18+)
  • Liver histology consistent with NAFLD/NASH performed within the past 24 months
  • Patients with cirrhosis must have ultrasound, computed tomography (CT) scan, or magnetic resonance imaging (MRI) examination of liver performed within the previous 6 months demonstrating no evidence for hepatocellular carcinoma

Exclusion Criteria:

  • Any liver disease beyond NAFLD/NASH
  • Severe congestive heart failure
  • Severe pulmonary hypertension
  • Chronic renal insufficiency defined by a serum creatinine above normal
  • Uncontrolled diabetes mellitus
  • Any autoimmune disorder which is currently being treated with immune suppressive medication
  • Proven or suspected hepatocellular carcinoma
  • Previous surgical bypass surgery for morbid obesity
  • Extensive small bowel resection
  • Patients currently receiving total parenteral nutrition
  • Recipients of any organ transplant
  • Women who are pregnant
  • Patients who, in the opinion of the investigator, should not be enrolled in this study

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 identifier (NCT number): NCT00244569

Layout table for location information
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Layout table for investigator information
Principal Investigator: Mitchell L. Shiffman, MD Virginia Commonwealth University


Layout table for additonal information
Responsible Party: Virginia Commonwealth University Identifier: NCT00244569     History of Changes
Other Study ID Numbers: OBID-2005-VCU
First Posted: October 26, 2005    Key Record Dates
Last Update Posted: March 20, 2017
Last Verified: March 2017

Keywords provided by Virginia Commonwealth University:
Nonalcoholic Fatty Liver Disease
Nonalcoholic Steatohepatitis
Liver Function

Additional relevant MeSH terms:
Layout table for MeSH terms
Liver Cirrhosis
Liver Diseases
Fatty Liver
Pathologic Processes
Digestive System Diseases