Prediction of Severity of Liver Disease by a 13C Octanoate Breath Test (OBT)
Recruitment status was Recruiting
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.
Nonalcoholic Fatty Liver Disease
Drug: Sodium Octanoate
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Prediction of Severity of Liver Disease in Patients With Suspected Nonalcoholic Fatty Liver Disease (NAFLD) by 13C Octanoate Breath Test (OBT)|
- PDR (percentage dose recovery) of OBT breath test [ Time Frame: 1 hour ] [ Designated as safety issue: No ]To assess the ability of the OBT to assess disease severity in patients with suspected NAFLD compared to NAS (CRN ) scoring system
- Histology -NAS scoring of liver biopsy [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]OBT will be compared to histology and other parameters to develop severity score. Only subjects with biopsy from routine clinical practice will be enrolled.
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Experimental: Subjects with suspected NAFLD and metabolic syndrome
Only subjects who have metabolic syndrome and are suspected of having non alcoholic fatty liver disease. They must not have any other liver disease (HCV...)
Drug: Sodium Octanoate
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.
Other Name: Octanaote, sodium octanoate
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 and transported rapidly to the liver through the portal venous system, enters the hepatic mitochondria independently of the carnitine transport system and undergoes hepatic mitochondrial beta-oxidation which produces acetyl coenzyme A (CoA). Finally, acetyl CoA enters the Krebs cycle and is oxidized by carbon dioxide (CO2). This is a non invasive test that can be performed routinely at every visit to assess disease severity. The subject is connected to a breath analyzer via a nasal cannula for approximately 1 hour, that measures baseline breath and changes in delta over baseline due to metabolization of Octanoate.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01244503
|Contact: Arun J Sanyal, MDfirstname.lastname@example.org|
|United States, Texas|
|Baylor College of Medicine||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: John M Vierling, MD 713-798-8355 email@example.com|
|Principal Investigator: John M Vierling, MD|
|United States, Virginia|
|Virginia Commonwealth University||Recruiting|
|Richmond, Virginia, United States, 23298|
|Contact: Arun J Sanyal, MD 804-828-4060 firstname.lastname@example.org|
|Contact: Jolene Schlosser, BSN 804-828-4060 email@example.com|
|Principal Investigator:||Arun J. Sanyal, M.D.||Virginia Commonwealth University|