Status:
TERMINATED
Prediction of Severity of Liver Disease by a 13C Octanoate Breath Test (OBT)
Lead Sponsor:
Virginia Commonwealth University
Collaborating Sponsors:
Meridian Bioscience, Inc.
Conditions:
Metabolic Syndrome
Nonalcoholic Fatty Liver Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 se...
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 an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT01244503
Start Date
February 1 2011
End Date
June 1 2012
Last Update
July 28 2015
Active Locations (2)
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1
Baylor College of Medicine
Houston, Texas, United States, 77030
2
Virginia Commonwealth University
Richmond, Virginia, United States, 23298