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Prediction of Severity of Liver Disease Non Alcoholic Fatty Liver Disease in Patients With Suspected NAFLD by a 13C Octanoate Breath Test

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2011 by Hadassah Medical Organization.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01281059
First Posted: January 21, 2011
Last Update Posted: August 28, 2012
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.
Collaborator:
Exalenz Bioscience LTD.
Information provided by:
Hadassah Medical Organization
  Purpose

The Exalenz clinical investigation is a multicenter, non-randomized, blinded, study of the ¹³C-Octanaote breath test (OBT). The OBT is a non-invasive test for evaluation of disease severity in patients with suspected non alcoholic fatty liver disease (NAFLD) The purpose of the study is to demonstrate that the ¹³C-Octanaote Breath Test (OBT) can be used as an aid, in conjunction with other clinical information and medical history, for evaluating disease severity and detecting non alcoholic steatohepatitis(NASH) with a high probability.

Retrospective analysis based on multivariable analysis will determined if and which demographic, clinical and biochemical or imaging techniques data can assist in addition to the data derived from OBT in differentiation of NASH, NAFL and possibly normals.


Condition Intervention
NAFLD Device: BreathID - Breath Test - 13C Octanoate

Study Type: Interventional

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Study Start Date: January 2011
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult men or women (>18 years of age)
  • Liver -biopsy ( at least 1.7 cm and 4 portal tracts) performed within 6 months of breath test or planned within the next 6 weeks, providing no treatment for liver disease was given between the biopsy and the OBT Any elevation of liver enzymes above the upper limit of normal (any or all of the following: AST,ALT, GGT, Alkaline phosphatase)
  • At least one of the features of the metabolic syndrome

    • waist circumference > 100 cm for men, 88 cm for women
    • triglycerides > 150 mg/dl
    • fasting blood sugar > 110 mg/dl
    • HDL cholesterol < 40 mg/dl
    • blood pressure > 130/85 mm Hg
  • No other known co-existent liver disease, excluded by appropriate serologic testing

Exclusion Criteria:

  • Positive studies for any of the following:
  • hepatitis C (PCR)
  • hepatitis B (surface antigen or DNA)
  • iron saturation > 60% + gene test for hereditary hemochromatosis
  • antinuclear antibody at a titer > 1: 160 along with hypergammaglobulinemia and ALT levels>250 U/L

    • Patient has Alpha-1-antitrypsin level below lower limit of normal (< 150 mg/dl)
    • Patient has alcohol consumption > 20 gm/day for women and > 30 gm/day for men
    • Patient is pregnant
    • Patient has been taking known hepatotoxic drugs e.g. (e.g.acebutolol, indomethacin,phenylbutazone,allopurinol,isoniazid,phenytoin,atenolol,ketoconazole,piroxicam,carbamazepine,labetalol,probenecid,cimetidine,maprotiline,pyrazinamide,dantrolene, metoprolol,quinidine,diclofenac, mianserin)• Patients that have had more than 10% reduction in body weight since biopsy
    • Patient with known severe congestive heart failure (LVEF on echocardiogram < 20%)
    • Patient with known severe pulmonary hypertension (By echocardiogram, PAS >45 mmHg)
    • Patient with uncontrolled diabetes mellitus (HA1c>10)
    • Patient with previous surgical bypass surgery
    • Patient with extensive short bowel syndrome(>100 cm)
    • Patient currently receiving total parenteral nutrition
    • Patient is a recipients of any organ transplant
    • Patients that received any anti-viral treatment or any other liver therapy between the time of the biopsy and the breath test.
    • Women who are pregnant
    • Patients with an acute current exacerbation of chronic obstructive pulmonary disease or bronchial asthma.
    • Patient has taken drugs that can interfere with octanoate metabolism or can also cause NAFLD independent of the metabolic syndrome, including: corticosteroids, amiodarone, tetracycline, valproic acid, methotrexate, stavudine, zidovudine.
    • Patients unable or refuse to sign informed consent
    • Patients that based on the opinion of the investigator should not be enrolled into this study
    • Patients that are participating in other clinical trials evaluating experimental treatments or procedures
  Contacts and Locations
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): NCT01281059


Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Exalenz Bioscience LTD.
  More Information

Responsible Party: Gadi Lalazar, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01281059     History of Changes
Other Study ID Numbers: 0429-10-HMO-CTIL
First Submitted: January 10, 2011
First Posted: January 21, 2011
Last Update Posted: August 28, 2012
Last Verified: August 2011

Additional relevant MeSH terms:
Non-alcoholic Fatty Liver Disease
Fatty Liver
Liver Diseases
Digestive System Diseases