Prediction of Severity of Liver Disease by a 13C Octanoate Breath Test (OBT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Virginia Commonwealth University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Exalenz Bioscience LTD.
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01244503
First received: November 17, 2010
Last updated: December 12, 2011
Last verified: December 2011
  Purpose

The purpose of the study is to demonstrate that the ¹³C-Octanoate Breath Test (OBT) can be used as an aid, in conjunction with other clinical information and medical history, for evaluating disease severity and detecting NASH with a high probability.


Condition Intervention Phase
Metabolic Syndrome
Nonalcoholic Fatty Liver Disease
Drug: Sodium Octanoate
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Prediction of Severity of Liver Disease in Patients With Suspected Nonalcoholic Fatty Liver Disease (NAFLD) by 13C Octanoate Breath Test (OBT)

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • PDR (percentage dose recovery) of OBT breath test [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    To assess the ability of the OBT to assess disease severity in patients with suspected NAFLD compared to NAS (CRN ) scoring system


Secondary Outcome Measures:
  • Histology -NAS scoring of liver biopsy [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    OBT will be compared to histology and other parameters to develop severity score. Only subjects with biopsy from routine clinical practice will be enrolled.


Estimated Enrollment: 150
Study Start Date: February 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Subjects with suspected NAFLD and metabolic syndrome
Only subjects who have metabolic syndrome and are suspected of having non alcoholic fatty liver disease. They must not have any other liver disease (HCV...)
Drug: Sodium Octanoate
100 mg of 13-C labeled sodium octanoate (Octanoate for short) is to be dissolved in 1 cup of tap water and administered to subject after baseline breath collection is completed.
Other Name: Octanaote, sodium octanoate

Detailed Description:

The OBT was chosen to assess, along with other parameters, liver health in subjects suspected of NAFLD (non alcoholic fatty liver disease).

Octanoate is absorbed promptly from the intestinal lumen and transported rapidly to the liver through the portal venous system, enters the hepatic mitochondria independently of the carnitine transport system and undergoes hepatic mitochondrial beta-oxidation which produces acetyl coenzyme A (CoA). Finally, acetyl CoA enters the Krebs cycle and is oxidized by carbon dioxide (CO2). This is a non invasive test that can be performed routinely at every visit to assess disease severity. The subject is connected to a breath analyzer via a nasal cannula for approximately 1 hour, that measures baseline breath and changes in delta over baseline due to metabolization of Octanoate.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01244503

Contacts
Contact: Arun J Sanyal, MD 804-828-4060 ajsanyal@vcu.edu

Locations
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: John M Vierling, MD    713-798-8355    vierling@bcm.fmc.edu   
Principal Investigator: John M Vierling, MD         
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Arun J Sanyal, MD    804-828-4060    ajsanyal@vcu.edu   
Contact: Jolene Schlosser, BSN    804-828-4060    jschlosser@vcu.edu   
Sponsors and Collaborators
Virginia Commonwealth University
Exalenz Bioscience LTD.
Investigators
Principal Investigator: Arun J. Sanyal, M.D. Virginia Commonwealth University
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01244503     History of Changes
Other Study ID Numbers: NASH-BID-FIS-808
Study First Received: November 17, 2010
Last Updated: December 12, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Liver Diseases
Metabolic Syndrome X
Fatty Liver
Digestive System Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 18, 2014