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

NCT01244503 | Terminated Phase 2 Results

• 1 other identifier: NASH-BID-FIS-808
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 2

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 severity and detecting NASH with a high probability.

Conditions

Metabolic Syndrome; Nonalcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

• The Peak Value of the PDR (Percentage Dose Recovery of 13C) of OBT (Octanoate Breath Test)

  To assess the ability of the OBT to assess disease severity in patients with suspected NAFLD (non alcoholic fatty liver disease) compared to NAS (Non-alcoholic-steatohepatitis (NASH) Activity Score) scoring system, where steatosis is scaled from 0-3, lobular inflammation is scaled from 0-3 and hepatocellular ballooning is scaled from 0-2. NAS score greater or equal to 5 indicates NASH. The higher the PDR peak, the better the liver health and function.PDR units are percent per hour of 13C dose recovery and describes rate of metabolism. The PDR peak is the highest rate of metabolism the liver reaches.The total range of NAS is 0-8.

  1 hour

Secondary Outcomes (1)

• Histology -NAS Scoring of Liver Biopsy

  Up to 6 months

Study Arms (1)

Sodium Octanoate Breath Test

EXPERIMENTAL

Only subjects with metabolic syndrome and suspected non alcoholic fatty liver disease will undergo breath test. They must not have any other liver disease.

Drug: Sodium Octanoate Breath Test

Interventions

Sodium Octanoate Breath Test DRUG

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.

Also known as: Octanaote, sodium octanoate

Sodium Octanoate Breath Test

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

• Virginia Commonwealth University: lead
• Meridian Bioscience, Inc.: collaborator

Study Sites (2)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome; Non-alcoholic Fatty Liver Disease

Interventions

octanoic acid

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Arun J Sanyal
• Organization: Virginia Commonwealth University

asanyal@mcvh-vcu.edu

804 828 6314

Study Officials

• Arun J. Sanyal, M.D.

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2010
• First Posted: November 19, 2010
• Study Start: February 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: June 1, 2012
• Last Updated: July 28, 2015
• Results First Posted: July 28, 2015

Record last verified: 2015-07

Locations

US (2)