Trial Outcomes & Findings for Biomarkers of Liver Pathology in Patients With Presumed Non-Alcoholic Steatohepatitis Following Bariatric Surgery (NCT NCT03294850)
NCT ID: NCT03294850
Last Updated: 2021-07-16
Results Overview
Assessed by magnetic resonance imaging proton density fat fraction (MRI PDFF)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
14 participants
Primary outcome timeframe
12 weeks
Results posted on
2021-07-16
Participant Flow
Recruitment began 7/18/2018 and concluded 12/3/2019. Participants were recruited from a local bariatric surgery medical practice.
Participant milestones
| Measure |
NASH Group
These are individuals that have been identified as having NASH by MRE. Confirmation with liver biopsy required for continuation in the longitudinal study.
Bariatric surgery: Subjects enrolling in the study who are undergoing bariatric surgery as part of their medical care will be studied
HepQuant SHUNT Dual Cholate Liver Diagnostic Kit: For the experimental group, the device will be used to monitor the effect of bariatric surgery on liver function. For the active comparator group, the device will be used for the assessment of baseline liver function.
|
Non-NASH (NAFLD or Normal) Group
These are individuals that do not have NASH. They either have normal liver physiology or only have evidence of hepatic steatosis. This group will be studied up until the day of their bariatric surgery and will serve as a comparator population with respect to baseline measurements.
Bariatric surgery: Subjects enrolling in the study who are undergoing bariatric surgery as part of their medical care will be studied
HepQuant SHUNT Dual Cholate Liver Diagnostic Kit: For the experimental group, the device will be used to monitor the effect of bariatric surgery on liver function. For the active comparator group, the device will be used for the assessment of baseline liver function.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
10
|
|
Overall Study
COMPLETED
|
4
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Biomarkers of Liver Pathology in Patients With Presumed Non-Alcoholic Steatohepatitis Following Bariatric Surgery
Baseline characteristics by cohort
| Measure |
NASH Group
n=4 Participants
These are individuals that have been identified as having NASH by MRE. Confirmation with liver biopsy required for continuation in the longitudinal study.
Bariatric surgery: Subjects enrolling in the study who are undergoing bariatric surgery as part of their medical care will be studied
HepQuant SHUNT Dual Cholate Liver Diagnostic Kit: For the experimental group, the device will be used to monitor the effect of bariatric surgery on liver function. For the active comparator group, the device will be used for the assessment of baseline liver function.
|
Non-NASH (NAFLD or Normal) Group
n=10 Participants
These are individuals that do not have NASH. They either have normal liver physiology or only have evidence of hepatic steatosis. This group will be studied up until the day of their bariatric surgery and will serve as a comparator population with respect to baseline measurements.
Bariatric surgery: Subjects enrolling in the study who are undergoing bariatric surgery as part of their medical care will be studied
HepQuant SHUNT Dual Cholate Liver Diagnostic Kit: For the experimental group, the device will be used to monitor the effect of bariatric surgery on liver function. For the active comparator group, the device will be used for the assessment of baseline liver function.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.750 years
STANDARD_DEVIATION 6.551 • n=5 Participants
|
38.600 years
STANDARD_DEVIATION 9.119 • n=7 Participants
|
39.21 years
STANDARD_DEVIATION 8.276 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
10 participants
n=7 Participants
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Only the NASH group had longitudinal evaluation
Assessed by magnetic resonance imaging proton density fat fraction (MRI PDFF)
Outcome measures
| Measure |
NASH Group
n=4 Participants
These are individuals that have been identified as having NASH by MRE. Confirmation with liver biopsy required for continuation in the longitudinal study.
Bariatric surgery: Subjects enrolling in the study who are undergoing bariatric surgery as part of their medical care will be studied
HepQuant SHUNT Dual Cholate Liver Diagnostic Kit: For the experimental group, the device will be used to monitor the effect of bariatric surgery on liver function. For the active comparator group, the device will be used for the assessment of baseline liver function.
|
Non-NASH (NAFLD or Normal) Group
These are individuals that do not have NASH. They either have normal liver physiology or only have evidence of hepatic steatosis. This group will be studied up until the day of their bariatric surgery and will serve as a comparator population with respect to baseline measurements.
Bariatric surgery: Subjects enrolling in the study who are undergoing bariatric surgery as part of their medical care will be studied
HepQuant SHUNT Dual Cholate Liver Diagnostic Kit: For the experimental group, the device will be used to monitor the effect of bariatric surgery on liver function. For the active comparator group, the device will be used for the assessment of baseline liver function.
|
|---|---|---|
|
Percent Change in Liver Fat Between Baseline and 12 Weeks Post-surgery
|
-16.4 percent change
Standard Deviation 52.9
|
—
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Only NASH group had longitudinal evaluation
We will evaluate change in liver stiffness, a surrogate for fibrosis, as assessed by magnetic resonance elastography (MRE)
Outcome measures
| Measure |
NASH Group
n=4 Participants
These are individuals that have been identified as having NASH by MRE. Confirmation with liver biopsy required for continuation in the longitudinal study.
Bariatric surgery: Subjects enrolling in the study who are undergoing bariatric surgery as part of their medical care will be studied
HepQuant SHUNT Dual Cholate Liver Diagnostic Kit: For the experimental group, the device will be used to monitor the effect of bariatric surgery on liver function. For the active comparator group, the device will be used for the assessment of baseline liver function.
|
Non-NASH (NAFLD or Normal) Group
These are individuals that do not have NASH. They either have normal liver physiology or only have evidence of hepatic steatosis. This group will be studied up until the day of their bariatric surgery and will serve as a comparator population with respect to baseline measurements.
Bariatric surgery: Subjects enrolling in the study who are undergoing bariatric surgery as part of their medical care will be studied
HepQuant SHUNT Dual Cholate Liver Diagnostic Kit: For the experimental group, the device will be used to monitor the effect of bariatric surgery on liver function. For the active comparator group, the device will be used for the assessment of baseline liver function.
|
|---|---|---|
|
Percent Change in Liver Stiffness Between Baseline and12 Weeks Post-surgery
|
1.9 percent change
Standard Deviation 10.4
|
—
|
Adverse Events
NASH Group
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Non-NASH (NAFLD or Normal) Group
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NASH Group
n=4 participants at risk
These are individuals that have been identified as having NASH by MRE. Confirmation with liver biopsy required for continuation in the longitudinal study.
Bariatric surgery: Subjects enrolling in the study who are undergoing bariatric surgery as part of their medical care will be studied
HepQuant SHUNT Dual Cholate Liver Diagnostic Kit: For the experimental group, the device will be used to monitor the effect of bariatric surgery on liver function. For the active comparator group, the device will be used for the assessment of baseline liver function.
|
Non-NASH (NAFLD or Normal) Group
n=10 participants at risk
These are individuals that do not have NASH. They either have normal liver physiology or only have evidence of hepatic steatosis. This group will be studied up until the day of their bariatric surgery and will serve as a comparator population with respect to baseline measurements.
Bariatric surgery: Subjects enrolling in the study who are undergoing bariatric surgery as part of their medical care will be studied
HepQuant SHUNT Dual Cholate Liver Diagnostic Kit: For the experimental group, the device will be used to monitor the effect of bariatric surgery on liver function. For the active comparator group, the device will be used for the assessment of baseline liver function.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Bruising, tenderness
|
0.00%
0/4 • 2.22 years
|
10.0%
1/10 • Number of events 1 • 2.22 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cyst in pituitaty
|
0.00%
0/4 • 2.22 years
|
10.0%
1/10 • Number of events 1 • 2.22 years
|
|
Ear and labyrinth disorders
Ear Infection
|
0.00%
0/4 • 2.22 years
|
10.0%
1/10 • Number of events 1 • 2.22 years
|
|
Gastrointestinal disorders
Gas Pain
|
0.00%
0/4 • 2.22 years
|
10.0%
1/10 • Number of events 1 • 2.22 years
|
|
Gastrointestinal disorders
H. Pylori Infection
|
0.00%
0/4 • 2.22 years
|
10.0%
1/10 • Number of events 1 • 2.22 years
|
|
General disorders
Headache
|
25.0%
1/4 • Number of events 1 • 2.22 years
|
10.0%
1/10 • Number of events 1 • 2.22 years
|
|
Gastrointestinal disorders
Inactive mild gastritis
|
0.00%
0/4 • 2.22 years
|
10.0%
1/10 • Number of events 1 • 2.22 years
|
|
Musculoskeletal and connective tissue disorders
Lower Leg Pain
|
25.0%
1/4 • Number of events 1 • 2.22 years
|
0.00%
0/10 • 2.22 years
|
|
General disorders
Migraine
|
0.00%
0/4 • 2.22 years
|
10.0%
1/10 • Number of events 1 • 2.22 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/4 • 2.22 years
|
10.0%
1/10 • Number of events 1 • 2.22 years
|
|
Musculoskeletal and connective tissue disorders
Right Arm Tenderness
|
0.00%
0/4 • 2.22 years
|
10.0%
1/10 • Number of events 1 • 2.22 years
|
|
Infections and infestations
Shingles
|
0.00%
0/4 • 2.22 years
|
10.0%
1/10 • Number of events 1 • 2.22 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Infection
|
0.00%
0/4 • 2.22 years
|
10.0%
1/10 • Number of events 1 • 2.22 years
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • 2.22 years
|
10.0%
1/10 • Number of events 1 • 2.22 years
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • 2.22 years
|
10.0%
1/10 • Number of events 1 • 2.22 years
|
|
Infections and infestations
Urinary Tract Infections
|
0.00%
0/4 • 2.22 years
|
10.0%
1/10 • Number of events 1 • 2.22 years
|
|
Metabolism and nutrition disorders
Vitamin D Defficiency
|
0.00%
0/4 • 2.22 years
|
10.0%
1/10 • Number of events 1 • 2.22 years
|
|
Cardiac disorders
Worsening Hypertension
|
25.0%
1/4 • Number of events 1 • 2.22 years
|
0.00%
0/10 • 2.22 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/4 • 2.22 years
|
10.0%
1/10 • Number of events 1 • 2.22 years
|
Additional Information
Dr. Karen Corbin
AdventHealth Translational Research Institute
Phone: (407) 303-7100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place