13C-Methacetin and Breath ID Machine in Fatty Liver and Cirrhosis - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Virginia
  - Richmond, Virginia, United States, 23298
    - Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
A p value of 0.05 or less will be considered significant.

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Collaborators

Oridion

Investigators

Principal Investigator: Mitchell L. Shiffman, MD, Virginia Commonwealth University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

October 24, 2005

First Submitted That Met QC Criteria