Trial Outcomes & Findings for Prediction of Severity of Liver Disease by a 13C Octanoate Breath Test (OBT) (NCT NCT01244503)

NCT ID: NCT01244503

Last Updated: 2015-07-28

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 61 participants
• Primary outcome timeframe: 1 hour
• Results posted on: 2015-07-28

Participant Flow

Participant milestones

Measure	Sodium Octanoate Breath Test 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 Study STARTED	61
Overall Study COMPLETED	61
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Sodium Octanoate Breath Test n=61 Participants 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.
Age, Continuous	50.1 years STANDARD_DEVIATION 12.6 • n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	57 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	54 participants n=5 Participants
Region of Enrollment Israel	7 participants n=5 Participants
Blood pressure diastolic	75 mmHg STANDARD_DEVIATION 10 • n=5 Participants
Blood pressure systolic	135 mmHg STANDARD_DEVIATION 18 • n=5 Participants
Weight	100 Kg STANDARD_DEVIATION 22 • n=5 Participants
Height	167 centimeters STANDARD_DEVIATION 21 • n=5 Participants

PRIMARY outcome

Timeframe: 1 hour

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.

Outcome measures

Measure

Sodium Octanoate Breath Test n=61 Participants 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.

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

23.27 PDR peak value (%/hour) Standard Deviation 4.93

SECONDARY outcome

Timeframe: Up to 6 months

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.

Outcome measures

Measure

Sodium Octanoate Breath Test n=61 Participants 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.

Histology -NAS Scoring of Liver Biopsy

3.71 units on a scale Standard Deviation 1.60

Adverse Events

Sodium Octanoate Breath Test

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Sodium Octanoate Breath Test n=61 participants at risk 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.
General disorders Pain	1.6% 1/61 • Number of events 1 No breath test related adverse events were reported
General disorders Lightheadedness	1.6% 1/61 • Number of events 1 No breath test related adverse events were reported
Endocrine disorders Hyperglycemia	1.6% 1/61 • Number of events 1 No breath test related adverse events were reported
Gastrointestinal disorders Odiferous breath	1.6% 1/61 • Number of events 1 No breath test related adverse events were reported

Additional Information

Arun J Sanyal

Virginia Commonwealth University

Phone: 804 828 6314

Email: asanyal@mcvh-vcu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60