Non-alcoholic Steatohepatitis (NASH)NCT05050721
Natural History of Non Alcoholic Fatty Liver Disease and Predictors of Advanced Fibrosis
An observational study of Non-alcoholic Steatohepatitis (NASH), run by Methodist Health System at 1 site in United States.
Trial summary
The prevalence of non-alcoholic fatty liver disease (NAFLD ) in the American population is approximately 30% in adults and 10% in children, making it the most common. Cause of chronic liver disease in the United States. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-alcoholic Steatohepatitis (NASH)
- What is being tested?
- CT imaging
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2019to 10 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: chronic liver disease registry and EPIC at liver institute and MDMC. All patients meeting the inclusion criteria will be included for the retrospective chart based study from Jan 2000 - Jan 2019.
Who may be able to join
- All patients both male and female greater than 18 years with radiologic or histologic evidence of fatty liver will be included in the study.
Who cannot join
- Patients with history of fatty liver less than 18 years of age.
- Patient's with fatty liver consuming alcohol up to greater than one drink per day.
- All fatty liver patients with other chronic liver disease such as hepatitis B, hepatitis C, primary biliary cirrhosis, primary biliary cholangitis, autoimmune hepatitis, alpha one antitrypsin disease or Wilsons disease superimposed on fatty liver disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Liver Institute at Methodist Dallas Medical Center
Irving, Texas, 75603
About this study
The prevalence of non-alcoholic fatty liver disease (NAFLD ) in the American population is approximately 30% in adults and 10% in children, making it the most common. Cause of chronic liver disease in the United States. Although the majority of patients with NAFLD have a benign clinical course, the development of non-alcoholic steatohepatitis (NASH ), with necro-inflammation and progressive fibrosis, increases the risk for development of cirrhosis and its complications. Among patients with NASH, approximately 28% develop cirrhosis over an 8-year follow-up period. NASH and advanced fibrosis is associated with increased morbidity and mortality among those patients with advanced histologic severity such as NASH and fibrosis the gold standard for diagnosing and staging NAFLD is liver biopsy. Liver biopsy is associated with costs and risks that make it impractical for generalized use in a condition that affects such a high portion of the population. Furthermore, liver biopsy is also limited by significant sampling error in NAFLD. Thus, there is a pressing need for accurate non-invasive predictors of NAFLD that would also allow differentiation of those subjects at higher risk of disease progression. At present, in the clinical setting, some demographic factors, blood tests, and imaging studies can be used to predict a higher risk of disease in patients being evaluated for NAFLD. These predictors, however, are of limited sensitivity and specificity compared with liver biopsy. The development and validation of accurate predictors and scoring systems to identify patients at higher risk for NASH and fibrosis would allow identification of subjects who would benefit the most from liver biopsy and potentially help monitor disease
Read the detailed description
It is a retrospective chart review study. All Methodist Dallas Medical Center (MDMC) patients with fatty liver diseases meeting the inclusion and exclusion criteria as mentioned below will be included in the study. Charts from Jan 2000 - Jan 2019 will be reviewed for data collection.
Data variables: age, weight, Height , BMI, gender, AST, ALT, Bilirubin, albumin, Alkaline phosphatase, WBC, PLT, Hb, sodium, potassium, creatinine, ferritin, insulin, glucose , HDL, LDL,VLDL, cholesterol, triglyceride. CT imaging, ultrasound findings, fibroscan, MR-Elastrography, liver biopsy results, presence of comorbidities like diabetes, hypertension and dyslipidemia
- Conditions
- Non-alcoholic Steatohepatitis (NASH)
- Being tested
- CT imaging
- Keywords
- Chronic liver disease, steatosis, inflammation, fibrosis
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver, Inflammation, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT imagingOther
Also called ultrasound, fibroscan, MR-Elastrography, liver biopsy
clinical, radiological and biochemical parameters associated with disease progression
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk factor (Age)
Age will be measured in years
Measured: 1 year
Risk factor (BMI)
Weight and height will be measured to determine BMI. it will be measured in kg/m^2.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study start4 Oct 2019
- Primary completion10 Aug 2021 (estimated)
- Study completion10 Sep 2021
Why it stopped: PI decided to stop the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Steatohepatitis (NASH)Studies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mangesh Pagadala, M.D., Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05050721
- Sponsor's protocol ID
- 043.HEP.2019.D
- Status last verified
- Dec 2021
- First submitted
- 22 Sep 2020
- Last updated
- 13 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History of Non Alcoholic Fatty Liver Disease and Predictors of Advanced Fibrosis
- ClinicalTrials.gov ID
- NCT05050721
- Acronym / sponsor ID
- 043.HEP.2019.D
- Conditions
- Non-alcoholic Steatohepatitis (NASH)
- Keywords
- Chronic liver disease, steatosis, inflammation, fibrosis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI decided to stop the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 4 Oct 2019 (actual)
- Primary completion
- 10 Aug 2021 (estimated)
- Study completion
- 10 Sep 2021 (actual)
- First posted
- 20 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The prevalence of non-alcoholic fatty liver disease (NAFLD ) in the American population is approximately 30% in adults and 10% in children, making it the most common. Cause of chronic liver disease in the United States. Although the majority of patients with NAFLD have a benign clinical course, the development of non-alcoholic steatohepatitis (NASH ), with necro-inflammation and progressive fibrosis, increases the risk for development of cirrhosis and its complications. Among patients with NASH, approximately 28% develop cirrhosis over an 8-year follow-up period. NASH and advanced fibrosis is associated with increased morbidity and mortality among those patients with advanced histologic severity such as NASH and fibrosis the gold standard for diagnosing and staging NAFLD is liver biopsy. Liver biopsy is associated with costs and risks that make it impractical for generalized use in a condition that affects such a high portion of the population. Furthermore, liver biopsy is also limited by significant sampling error in NAFLD. Thus, there is a pressing need for accurate non-invasive predictors of NAFLD that would also allow differentiation of those subjects at higher risk of disease progression. At present, in the clinical setting, some demographic factors, blood tests, and imaging studies can be used to predict a higher risk of disease in patients being evaluated for NAFLD. These predictors, however, are of limited sensitivity and specificity compared with liver biopsy. The development and validation of accurate predictors and scoring systems to identify patients at higher risk for NASH and fibrosis would allow identification of subjects who would benefit the most from liver biopsy and potentially help monitor disease
Detailed description
It is a retrospective chart review study. All Methodist Dallas Medical Center (MDMC) patients with fatty liver diseases meeting the inclusion and exclusion criteria as mentioned below will be included in the study. Charts from Jan 2000 - Jan 2019 will be reviewed for data collection.
Data variables: age, weight, Height , BMI, gender, AST, ALT, Bilirubin, albumin, Alkaline phosphatase, WBC, PLT, Hb, sodium, potassium, creatinine, ferritin, insulin, glucose , HDL, LDL,VLDL, cholesterol, triglyceride. CT imaging, ultrasound findings, fibroscan, MR-Elastrography, liver biopsy results, presence of comorbidities like diabetes, hypertension and dyslipidemia
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- chronic liver disease registry and EPIC at liver institute and MDMC. All patients meeting the inclusion criteria will be included for the retrospective chart based study from Jan 2000 - Jan 2019.
Key inclusion criteria (1 listed)
- All patients both male and female greater than 18 years with radiologic or histologic evidence of fatty liver will be included in the study.
Key exclusion criteria (3 listed)
- Patients with history of fatty liver less than 18 years of age.
- Patient's with fatty liver consuming alcohol up to greater than one drink per day.
- All fatty liver patients with other chronic liver disease such as hepatitis B, hepatitis C, primary biliary cirrhosis, primary biliary cholangitis, autoimmune hepatitis, alpha one antitrypsin disease or Wilsons disease superimposed on fatty liver disease.
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 |
|---|---|---|
| CT imagingAlso: ultrasound, fibroscan, MR-Elastrography, liver biopsyclinical, radiological and biochemical parameters associated with disease progression | Other | – |
Primary outcome
Risk factor (Age)
Time frame: 1 year
Age will be measured in years
Risk factor (BMI)
Time frame: 1 year
Weight and height will be measured to determine BMI. it will be measured in kg/m^2.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2021.
- Individual participant dataSharing planned: Undecided
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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.
Mangesh Pagadala, M.D. principal investigator
The Methodist Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-alcoholic Steatohepatitis (NASH), run by Methodist Health System at 1 site in United States.
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 1 inclusion and 3 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: withdrawn, as of the sponsor's last update on 13 Dec 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Risk factor (Age) (time frame: 1 year). 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?
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 13 Dec 2021.