Prediction of Severity of Liver Disease Non Alcoholic Fatty Liver Disease in Patients With Suspected NAFLD by a 13C Octanoate Breath Test

NCT01281059 | Unknown DMC

• 1 other identifier: 0429-10-HMO-CTIL
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

NAFLD

Interventions

BreathID - Breath Test - 13C Octanoate DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Hadassah Medical Organization: lead
• Meridian Bioscience, Inc.: collaborator

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 10, 2011
• First Posted: January 21, 2011
• Study Start: January 1, 2011
• Last Updated: August 28, 2012

Record last verified: 2011-08

Locations

IL (1)