NASH - Nonalcoholic Steatohepatitis; NAFLD - Nonalcoholic Fatty Liver DiseaseBARINCT03294850

Biomarkers of Liver Pathology in Patients With Presumed Non-Alcoholic Steatohepatitis Following Bariatric Surgery

A study testing Bariatric surgery and HepQuant SHUNT Dual Cholate Liver Diagnostic Kit in people with NASH - Nonalcoholic Steatohepatitis; NAFLD - Nonalcoholic Fatty Liver Disease, run by AdventHealth Translational Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to evaluate imaging and other biomarkers of non-alcoholic fatty liver disease before and after bariatric surgery. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: NASH - Nonalcoholic Steatohepatitis; NAFLD - Nonalcoholic Fatty Liver Disease
What is being tested?: Bariatric surgery and HepQuant SHUNT Dual Cholate Liver Diagnostic Kit
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteUnited States
Study dates: 18 Jul 2018to 11 Sep 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Age ≥18 years
Undergoing bariatric surgery (Roux-en-Y or gastric sleeve only) as part of clinical care.
Negative human chorionic gonadotropin (hCG) level (female participants who become pregnant during the study will be withdrawn)
For nonalcoholic steatohepatitis (NASH) participants - FibroScan: Controlled Attenuation Parameter (CAP) 290 db/m and Vibration-Controlled Transient Elastography (VCTE) 8 kilopascal (kPa). For participants who meet FibroScan criteria, inclusion will require MRI-PDFF ≥8%; MRE: ≥2.7 kPa.
For NAFLD or normal participants - FibroScan: No requirement for minimum CAP level and VCTE <7 kPa. For participants that meet the FibroScan criteria- no requirement for minimum MRI-PDFF; MRE ≤ 2 kPa.
Histopathology assessment of liver biopsy that confirms NASH diagnosis

Show all 12Show fewer

Hemoglobin A1c (HbA1c) ≤ 9.5%
Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)
Body mass index (BMI) ≥ 35 kg/m2
Able to speak and understand written and spoken English
Understands the procedures and agrees to participate by giving written informed consent
Willing and able to comply with scheduled visits, laboratory tests, and other study procedures

Who cannot join

Participation in other studies involving investigational drug(s) within 30 days prior to Screening Visit 1
History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males within the previous 6 months
A total score of 8 on the Alcohol Use Disorders Identification Test questionnaire (Appendix B), indicating harmful or hazardous ethanol consumption
A positive urine drug test for illicit drugs
Clinical evidence of hepatic decompensation, including, but not limited to esophageal varices, ascites, or hepatic encephalopathy
Evidence of other forms of chronic liver disease (including laboratory tests as assessed by a sponsor-identified laboratory, and confirmed with a single repeat, if needed): Hepatitis B virus (HBV): defined by presence of hepatitis B surface antigen (HBsAg); Hepatitis C virus (HCV): As defined by a clinical history of previous diagnosis of Hepatitis C (treated or untreated) or a positive Hepatitis C antibody (HCVAb); Known diagnosis of primary biliary cirrhosis, primary sclerosing cholangitis, autoimmune hepatitis, or overlap syndrome; Alcoholic liver disease; Known diagnosis of hemochromatosis; Prior known drug-induced liver injury; Known or suspected hepatocellular carcinoma (HCC) or other liver cancer; History of liver transplant, current placement on a liver transplant list, or current model of end-stage liver disease (MELD) score >12; Histological presence of cirrhosis on a prior biopsy.

Show all 18Show fewer

Human Immunodeficiency Virus (HIV) infection, defined as presence of HIV antibody
Diagnosis of type 1 diabetes mellitus
Any malignancy not considered cured, except basal cell carcinoma and squamous cell carcinoma of the skin (a subject is considered cured if there has been no evidence of cancer recurrence in the previous 5 years)
Use of drugs historically associated with non-alcoholic fatty liver disease (NAFLD) for 1 month in the previous year prior to Visit 3 (day of Surgery); examples include: amiodarone, methotrexate, systemic glucocorticoids, tetracyclines, tamoxifen, estrogens at doses greater than those used for hormone replacement, anabolic steroids, valproic acid, other known hepatotoxins
Subjects with history of severe claustrophobia impacting ability to perform MRI during the study without mild sedation/treatment with an anxiolytic
Subjects who fulfill any of the contraindications for MRI; examples include metal implants, devices, paramagnetic objects contained within the body and excessive or metal-containing tattoos
Unable to participate in MR assessments due to physical limitations of equipment tolerances (MRI bore size and 500-pound weight limit) based on Investigator's judgment at screening
Any person unable to lie still within the environment of the MRI scanner or maintain a breath hold for the required period to acquire images without mild sedation/treatment with an anxiolytic
Subjects with any anatomical or pathological abnormality that would either preclude or tend to confound the analysis of study data, including any clinically significant abnormal findings on the MRI obtained at Screening Visit 2.
Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to Screening Visit 1 (participants may not donate blood any time during the study, through the final study visit)
Known history or suspected hypersensitivity to human serum albumin, or its preparations.
Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study

Trial locations and contacts

1 site in 1 country.

United States1 site

Translational Research Institute for Metabolism and Diabetes
Orlando, Florida, 32804

Other trials in United States

About this study

Official title: Evaluation of Biomarkers to Quantify Liver Pathology in Patients With Presumed Non-Alcoholic Steatohepatitis at Baseline and Following Bariatric Surgery (BARI)

The purpose of this study is to evaluate imaging and other biomarkers of non-alcoholic fatty liver disease before and after bariatric surgery.

Conditions: NASH - Nonalcoholic Steatohepatitis; NAFLD - Nonalcoholic Fatty Liver Disease
Being tested: Bariatric surgery, HepQuant SHUNT Dual Cholate Liver Diagnostic Kit
Medical subject headings: Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bariatric surgeryProcedure or 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 KitDevice
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.

Study groups in NCT03294850
Study group	Role	What they receive
NASH group	Experimental	These are individuals that have been identified as having NASH by MRE. Confirmation with liver biopsy required for continuation in the longitudinal study. Receives: Procedure: Bariatric surgery; Device: HepQuant SHUNT Dual Cholate Liver Diagnostic Kit
Non-NASH (NAFLD or normal) group	Active comparator	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. Receives: Procedure: Bariatric surgery; Device: HepQuant SHUNT Dual Cholate Liver Diagnostic Kit

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change in Liver Fat Between Baseline and 12 Weeks Post-surgery
Assessed by magnetic resonance imaging proton density fat fraction (MRI PDFF)
Measured: 12 weeks
Percent Change in Liver Stiffness Between Baseline and12 Weeks Post-surgery
We will evaluate change in liver stiffness, a surrogate for fibrosis, as assessed by magnetic resonance elastography (MRE)
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Jul 201811 Sep 2020

First posted27 Sep 2017
Study start18 Jul 2018
Primary completion14 Nov 2019
Study completion11 Sep 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (27)Papers the sponsor has linked to this study.
Other trials for NASH - Nonalcoholic Steatohepatitis; NAFLD - Nonalcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03294850
Sponsor's protocol ID: TRIMDFH 1000376
Acronym: BARI
Status last verified: Jul 2021
First submitted: 22 Sep 2017
Last updated: 16 Jul 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Ahmed MH, Abu EO, Byrne CD. Non-Alcoholic Fatty Liver Disease (NAFLD): new challenge for general practitioners and important burden for health authorities? Prim Care Diabetes. 2010 Oct;4(3):129-37. doi: 10.1016/j.pcd.2010.02.004. Epub 2010 Mar 17.
PubMed 20299294
Loomba R, Sanyal AJ. The global NAFLD epidemic. Nat Rev Gastroenterol Hepatol. 2013 Nov;10(11):686-90. doi: 10.1038/nrgastro.2013.171. Epub 2013 Sep 17.
PubMed 24042449
Vernon G, Baranova A, Younossi ZM. Systematic review: the epidemiology and natural history of non-alcoholic fatty liver disease and non-alcoholic steatohepatitis in adults. Aliment Pharmacol Ther. 2011 Aug;34(3):274-85. doi: 10.1111/j.1365-2036.2011.04724.x. Epub 2011 May 30.
PubMed 21623852
Sanyal AJ, Friedman SL, McCullough AJ, Dimick-Santos L; American Association for the Study of Liver Diseases; United States Food and Drug Administration. Challenges and opportunities in drug and biomarker development for nonalcoholic steatohepatitis: findings and recommendations from an American Association for the Study of Liver Diseases-U.S. Food and Drug Administration Joint Workshop. Hepatology. 2015 Apr;61(4):1392-405. doi: 10.1002/hep.27678. Epub 2015 Mar 19.
PubMed 25557690
Cohen JC, Horton JD, Hobbs HH. Human fatty liver disease: old questions and new insights. Science. 2011 Jun 24;332(6037):1519-23. doi: 10.1126/science.1204265.
PubMed 21700865
Ratziu V, Charlotte F, Heurtier A, Gombert S, Giral P, Bruckert E, Grimaldi A, Capron F, Poynard T; LIDO Study Group. Sampling variability of liver biopsy in nonalcoholic fatty liver disease. Gastroenterology. 2005 Jun;128(7):1898-906. doi: 10.1053/j.gastro.2005.03.084.
PubMed 15940625
Alkhouri N, McCullough AJ. Noninvasive Diagnosis of NASH and Liver Fibrosis Within the Spectrum of NAFLD. Gastroenterol Hepatol (N Y). 2012 Oct;8(10):661-8.
PubMed 24683373
Papagianni M, Sofogianni A, Tziomalos K. Non-invasive methods for the diagnosis of nonalcoholic fatty liver disease. World J Hepatol. 2015 Apr 8;7(4):638-48. doi: 10.4254/wjh.v7.i4.638.
PubMed 25866601
Dulai PS, Sirlin CB, Loomba R. MRI and MRE for non-invasive quantitative assessment of hepatic steatosis and fibrosis in NAFLD and NASH: Clinical trials to clinical practice. J Hepatol. 2016 Nov;65(5):1006-1016. doi: 10.1016/j.jhep.2016.06.005. Epub 2016 Jun 14.
PubMed 27312947
Hashemi SA, Alavian SM, Gholami-Fesharaki M. Assessment of transient elastography (FibroScan) for diagnosis of fibrosis in non-alcoholic fatty liver disease: A systematic review and meta-analysis. Caspian J Intern Med. 2016 Fall;7(4):242-252.
PubMed 27999641
Barker KB, Palekar NA, Bowers SP, Goldberg JE, Pulcini JP, Harrison SA. Non-alcoholic steatohepatitis: effect of Roux-en-Y gastric bypass surgery. Am J Gastroenterol. 2006 Feb;101(2):368-73. doi: 10.1111/j.1572-0241.2006.00419.x.
PubMed 16454845
Rabl C, Campos GM. The impact of bariatric surgery on nonalcoholic steatohepatitis. Semin Liver Dis. 2012 Feb;32(1):80-91. doi: 10.1055/s-0032-1306428. Epub 2012 Mar 13.
PubMed 22418890
Hafeez S, Ahmed MH. Bariatric surgery as potential treatment for nonalcoholic fatty liver disease: a future treatment by choice or by chance? J Obes. 2013;2013:839275. doi: 10.1155/2013/839275. Epub 2013 Jan 29.
PubMed 23431426
Schneck AS, Anty R, Patouraux S, Bonnafous S, Rousseau D, Lebeaupin C, Bailly-Maitre B, Sans A, Tran A, Gugenheim J, Iannelli A, Gual P. Roux-En Y Gastric Bypass Results in Long-Term Remission of Hepatocyte Apoptosis and Hepatic Histological Features of Non-alcoholic Steatohepatitis. Front Physiol. 2016 Aug 19;7:344. doi: 10.3389/fphys.2016.00344. eCollection 2016.
PubMed 27594839
Alizai PH, Wendl J, Roeth AA, Klink CD, Luedde T, Steinhoff I, Neumann UP, Schmeding M, Ulmer F. Functional Liver Recovery After Bariatric Surgery--a Prospective Cohort Study with the LiMAx Test. Obes Surg. 2015 Nov;25(11):2047-53. doi: 10.1007/s11695-015-1664-0.
PubMed 25869925

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All NASH - Nonalcoholic Steatohepatitis; NAFLD - Nonalcoholic Fatty Liver Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Biomarkers to Quantify Liver Pathology in Patients With Presumed Non-Alcoholic Steatohepatitis at Baseline and Following Bariatric Surgery (BARI)
ClinicalTrials.gov ID: NCT03294850
Acronym / sponsor ID: BARI / TRIMDFH 1000376
Conditions: NASH - Nonalcoholic Steatohepatitis; NAFLD - Nonalcoholic Fatty Liver Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: AdventHealth Translational Research InstituteUniversity, hospital or other
Study start: 18 Jul 2018 (actual)
Primary completion: 14 Nov 2019 (actual)
Study completion: 11 Sep 2020 (actual)
First posted: 27 Sep 2017 (actual)
Results: Posted 14 Jun 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate imaging and other biomarkers of non-alcoholic fatty liver disease before and after bariatric surgery.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
NASH group	Experimental	Procedure: Bariatric surgery, Device: HepQuant SHUNT Dual Cholate Liver Diagnostic KitThese are individuals that have been identified as having NASH by MRE. Confirmation with liver biopsy required for continuation in the longitudinal study.
Non-NASH (NAFLD or normal) group	Active comparator	Procedure: Bariatric surgery, Device: HepQuant SHUNT Dual Cholate Liver Diagnostic KitThese 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Age ≥18 years
Undergoing bariatric surgery (Roux-en-Y or gastric sleeve only) as part of clinical care.
Negative human chorionic gonadotropin (hCG) level (female participants who become pregnant during the study will be withdrawn)
For nonalcoholic steatohepatitis (NASH) participants - FibroScan: Controlled Attenuation Parameter (CAP) 290 db/m and Vibration-Controlled Transient Elastography (VCTE) 8 kilopascal (kPa). For participants who meet FibroScan criteria, inclusion will require MRI-PDFF ≥8%; MRE: ≥2.7 kPa.
For NAFLD or normal participants - FibroScan: No requirement for minimum CAP level and VCTE <7 kPa. For participants that meet the FibroScan criteria- no requirement for minimum MRI-PDFF; MRE ≤ 2 kPa.

Key exclusion criteria (18 listed)

Participation in other studies involving investigational drug(s) within 30 days prior to Screening Visit 1
History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males within the previous 6 months
A total score of 8 on the Alcohol Use Disorders Identification Test questionnaire (Appendix B), indicating harmful or hazardous ethanol consumption
A positive urine drug test for illicit drugs
Clinical evidence of hepatic decompensation, including, but not limited to esophageal varices, ascites, or hepatic encephalopathy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Bariatric surgerySubjects enrolling in the study who are undergoing bariatric surgery as part of their medical care will be studied	Procedure or surgery	NASH group, Non-NASH (NAFLD or normal) group
HepQuant SHUNT Dual Cholate Liver Diagnostic KitFor 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.	Device	NASH group, Non-NASH (NAFLD or normal) group

Primary outcome

Percent Change in Liver Fat Between Baseline and 12 Weeks Post-surgery
Time frame: 12 weeks
Assessed by magnetic resonance imaging proton density fat fraction (MRI PDFF)
Percent Change in Liver Stiffness Between Baseline and12 Weeks Post-surgery
Time frame: 12 weeks
We will evaluate change in liver stiffness, a surrogate for fibrosis, as assessed by magnetic resonance elastography (MRE)

Results and safety

Results posted to the registry on 14 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NASH Group	4	4
Non-NASH (NAFLD or Normal) Group	10	10

Primary outcome: Percent Change in Liver Fat Between Baseline and 12 Weeks Post-surgery

Time frame: 12 weeks. Mean (Standard Deviation). Unit: percent change

Measure	NASH Group n = 4	Non-NASH (NAFLD or Normal) Group n = 0
Value	-16.4 (52.9)	–

Population analysed: Only the NASH group had longitudinal evaluation

Primary outcome: Percent Change in Liver Stiffness Between Baseline and12 Weeks Post-surgery

Time frame: 12 weeks. Mean (Standard Deviation). Unit: percent change

Measure	NASH Group n = 4	Non-NASH (NAFLD or Normal) Group n = 0
Value	1.9 (10.4)	–

Population analysed: Only NASH group had longitudinal evaluation

Adverse events

Time frame: 2.22 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NASH Group	0 of 4 (0%)	2 of 4 (50%)	0 of 4
Non-NASH (NAFLD or Normal) Group	0 of 10 (0%)	9 of 10 (90%)	0 of 10

Limitations and caveats (from the sponsor): This trial was limited by the need to close the trial prior to enrolling all participants due to extreme difficulties with recruitment. Based on our power estimates, we needed 25 people in the NASH group, and we were only able to enroll 4. Therefore, our analyses will be limited the basic plans proposed in the protocol and will likely be exploratory and hypothesis generating in nature.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 20299294Ahmed MH, Abu EO, Byrne CD. Non-Alcoholic Fatty Liver Disease (NAFLD): new challenge for general practitioners and important burden for health authorities? Prim Care Diabetes. 2010 Oct;4(3):129-37. doi: 10.1016/j.pcd.2010.02.004. Epub 2010 Mar 17.
Background: PubMed 24042449Loomba R, Sanyal AJ. The global NAFLD epidemic. Nat Rev Gastroenterol Hepatol. 2013 Nov;10(11):686-90. doi: 10.1038/nrgastro.2013.171. Epub 2013 Sep 17.
Background: PubMed 21623852Vernon G, Baranova A, Younossi ZM. Systematic review: the epidemiology and natural history of non-alcoholic fatty liver disease and non-alcoholic steatohepatitis in adults. Aliment Pharmacol Ther. 2011 Aug;34(3):274-85. doi: 10.1111/j.1365-2036.2011.04724.x. Epub 2011 May 30.
Background: PubMed 25557690Sanyal AJ, Friedman SL, McCullough AJ, Dimick-Santos L; American Association for the Study of Liver Diseases; United States Food and Drug Administration. Challenges and opportunities in drug and biomarker development for nonalcoholic steatohepatitis: findings and recommendations from an American Association for the Study of Liver Diseases-U.S. Food and Drug Administration Joint Workshop. Hepatology. 2015 Apr;61(4):1392-405. doi: 10.1002/hep.27678. Epub 2015 Mar 19.
Background: PubMed 21700865Cohen JC, Horton JD, Hobbs HH. Human fatty liver disease: old questions and new insights. Science. 2011 Jun 24;332(6037):1519-23. doi: 10.1126/science.1204265.
Background: PubMed 15940625Ratziu V, Charlotte F, Heurtier A, Gombert S, Giral P, Bruckert E, Grimaldi A, Capron F, Poynard T; LIDO Study Group. Sampling variability of liver biopsy in nonalcoholic fatty liver disease. Gastroenterology. 2005 Jun;128(7):1898-906. doi: 10.1053/j.gastro.2005.03.084.
Background: PubMed 24683373Alkhouri N, McCullough AJ. Noninvasive Diagnosis of NASH and Liver Fibrosis Within the Spectrum of NAFLD. Gastroenterol Hepatol (N Y). 2012 Oct;8(10):661-8.
Background: PubMed 25866601Papagianni M, Sofogianni A, Tziomalos K. Non-invasive methods for the diagnosis of nonalcoholic fatty liver disease. World J Hepatol. 2015 Apr 8;7(4):638-48. doi: 10.4254/wjh.v7.i4.638.
Background: PubMed 27312947Dulai PS, Sirlin CB, Loomba R. MRI and MRE for non-invasive quantitative assessment of hepatic steatosis and fibrosis in NAFLD and NASH: Clinical trials to clinical practice. J Hepatol. 2016 Nov;65(5):1006-1016. doi: 10.1016/j.jhep.2016.06.005. Epub 2016 Jun 14.
Background: PubMed 27999641Hashemi SA, Alavian SM, Gholami-Fesharaki M. Assessment of transient elastography (FibroScan) for diagnosis of fibrosis in non-alcoholic fatty liver disease: A systematic review and meta-analysis. Caspian J Intern Med. 2016 Fall;7(4):242-252.
Background: PubMed 16454845Barker KB, Palekar NA, Bowers SP, Goldberg JE, Pulcini JP, Harrison SA. Non-alcoholic steatohepatitis: effect of Roux-en-Y gastric bypass surgery. Am J Gastroenterol. 2006 Feb;101(2):368-73. doi: 10.1111/j.1572-0241.2006.00419.x.
Background: PubMed 22418890Rabl C, Campos GM. The impact of bariatric surgery on nonalcoholic steatohepatitis. Semin Liver Dis. 2012 Feb;32(1):80-91. doi: 10.1055/s-0032-1306428. Epub 2012 Mar 13.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Steven Smith, MD principal investigator

Study Principal Investigator

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change in Liver Fat Between Baseline and 12 Weeks Post-surgery (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03294850, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2021.