Prediction of Severity of Liver Disease by a 13C Octanoate Breath Test (OBT)
Condition: Metabolic Syndrome; Nonalcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Metabolic Syndrome
Intervention: Sodium Octanoate Breath Test
Intervention description: 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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 severity and detecting NASH with a high probability.
    

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