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

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ClinicalTrials.gov Identifier: NCT01244503
Recruitment Status : Terminated (Budgetary Issues)
First Posted : November 19, 2010
Results First Posted : July 28, 2015
Last Update Posted : July 28, 2015
Sponsor:
Collaborator:
Exalenz Bioscience LTD.
Information provided by (Responsible Party):
Virginia Commonwealth University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Metabolic Syndrome
Nonalcoholic Fatty Liver Disease
Intervention Drug: Sodium Octanoate Breath Test
Enrollment 61
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sodium Octanoate Breath Test
Hide Arm/Group Description

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

Sodium Octanoate Breath Test: 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.

Period Title: Overall Study
Started 61
Completed 61
Not Completed 0
Arm/Group Title Sodium Octanoate Breath Test
Hide Arm/Group Description

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

Sodium Octanoate Breath Test: 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.

Overall Number of Baseline Participants 61
Hide Baseline Analysis Population Description
Only subjects with metabolic syndrome and suspected non alcoholic fatty liver disease will undergo breath test. They must not have any other liver disease.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 61 participants
50.1  (12.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants
Female
41
  67.2%
Male
20
  32.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
   4.9%
White
57
  93.4%
More than one race
1
   1.6%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 61 participants
United States 54
Israel 7
Blood pressure diastolic  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 61 participants
75  (10)
Blood pressure systolic  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 61 participants
135  (18)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 61 participants
100  (22)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 61 participants
167  (21)
1.Primary Outcome
Title The Peak Value of the PDR (Percentage Dose Recovery of 13C) of OBT (Octanoate Breath Test)
Hide Description 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.
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sodium Octanoate Breath Test
Hide Arm/Group Description:

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

Sodium Octanoate Breath Test: 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.

Overall Number of Participants Analyzed 61
Mean (Standard Deviation)
Unit of Measure: PDR peak value (%/hour)
23.27  (4.93)
2.Secondary Outcome
Title Histology -NAS Scoring of Liver Biopsy
Hide Description

OBT will be compared to histology (including NAS score as described above)and other parameters to develop severity score. Only subjects with biopsy from routine clinical practice will be enrolled.

NAS (Non-alcoholic-steatohepatitis (NASH) Activity Score) scoring system includes the following components: steatosis, which is scaled from 0-3, lobular inflammation, which is scaled from 0-3 and hepatocellular ballooning, which is scaled from 0-2. NAS score greater or equal to 5 indicates NASH. The range of the NAS score is from 0-8.

Time Frame Up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sodium Octanoate Breath Test
Hide Arm/Group Description:

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

Sodium Octanoate Breath Test: 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.

Overall Number of Participants Analyzed 61
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.71  (1.60)
Time Frame [Not Specified]
Adverse Event Reporting Description No breath test related adverse events were reported
 
Arm/Group Title Sodium Octanoate Breath Test
Hide Arm/Group Description

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

Sodium Octanoate Breath Test: 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.

All-Cause Mortality
Sodium Octanoate Breath Test
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sodium Octanoate Breath Test
Affected / at Risk (%) # Events
Total   0/61 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Sodium Octanoate Breath Test
Affected / at Risk (%) # Events
Total   4/61 (6.56%)    
Endocrine disorders   
Hyperglycemia *  1/61 (1.64%)  1
Gastrointestinal disorders   
Odiferous breath *  1/61 (1.64%)  1
General disorders   
Pain * [1]  1/61 (1.64%)  1
Lightheadedness * [2]  1/61 (1.64%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Upper right quadrant pain
[2]
Non liver related
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Arun J Sanyal
Organization: Virginia Commonwealth University
Phone: 804 828 6314
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01244503     History of Changes
Other Study ID Numbers: NASH-BID-FIS-808
First Submitted: November 17, 2010
First Posted: November 19, 2010
Results First Submitted: August 7, 2014
Results First Posted: July 28, 2015
Last Update Posted: July 28, 2015