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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

Primary Purpose

NAFLD

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
BreathID - Breath Test - 13C Octanoate
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional trial for NAFLD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hadassah Medical Organization

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 10, 2011
Last Updated
August 27, 2012
Sponsor
Hadassah Medical Organization
Collaborators
Meridian Bioscience, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01281059
Brief Title
Prediction of Severity of Liver Disease Non Alcoholic Fatty Liver Disease in Patients With Suspected NAFLD by a 13C Octanoate Breath Test
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hadassah Medical Organization
Collaborators
Meridian Bioscience, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NAFLD

7. Study Design

Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
BreathID - Breath Test - 13C Octanoate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
Country
Israel

12. IPD Sharing Statement

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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

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