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

Stopped early · Phase 2

Conditions studied: Metabolic Syndrome, Nonalcoholic Fatty Liver Disease

In brief

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.

Key facts

Study ID: NCT01244503
Run by: Virginia Commonwealth University
People needed: 61
Starts: 2011-02-01
Expected to finish: 2012-06-01
Last updated by the study team: 2015-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Baylor College of Medicine — Houston, Texas, United States
Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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