Morbid ObesityFIRMNCT01695083
Non Invasive Measurements of Fibrosis, Inflammation and Steatohepatitis in Morbidly Obese Patients
An observational study of Morbid Obesity and Non Alcoholic Steatohepatitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Abstract: Fatty liver most frequently corresponds to a fat overload of the liver. It is usually classified as alcoholic steatosis or non-alcoholic steatosis. In the case of non alcoholic fatty liver overload, the histological spectrum ranges from simple steatosis to steatohepatitis (NASH) which associates inflammation… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Morbid Obesity, Non Alcoholic Steatohepatitis
- How many people
- 186 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2012to Nov 2015
- 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
- No healthy volunteers
- Adult, Older adult
Study population: morbidly obese patients undergoing bariatric surgery
Who may be able to join
- Age ≥ 18 years
- BMI ≥ 35 kg/m2
- Bariatric surgery scheduled within 3 months following the inclusion
- Conducting a medical examination.
- Signature of informed consent
Who cannot join
- Patient non-affiliated to a social security scheme (beneficiary or assignee)
- Cons-indication for performing an MRI
- weight> 230 kg , anteroposterior diameter>40 cm
- Cancer treatment or medication that may induce lesions of steatohepatitis (corticoids, methotrexate, amiodarone, perhexiline, tamoxifen, nifedipine, diltiazem, hycanthone)
- Alcohol consumption > 20 g per day for women and > 30 g per day for men AND no past history of excessive alcohol use for more than a 2-year period within the last 20 years
- known chronic liver disease other than steatosis (presence of HBs antigen, or antibody to HCV, or anti-nuclear antibodies, anti-mitochondria, anti-LKM1, anti-smooth muscle negative, or the presence of a hemochromatosis),
- known HIV positive status
- Pregnant women (known pregnancy) or lactating
Trial locations and contacts
1 site in 1 country.
About this study
Abstract:
Fatty liver most frequently corresponds to a fat overload of the liver. It is usually classified as alcoholic steatosis or non-alcoholic steatosis. In the case of non alcoholic fatty liver overload, the histological spectrum ranges from simple steatosis to steatohepatitis (NASH) which associates inflammation to steatosis, with a risk of progression to fibrosis and cirrhosis. Obese patients are at particular risk of NASH. Screening of these hepatic lesions is difficult especially as they may exist while the liver tests are normal. The diagnosis of NASH is currently done by liver biopsy, which exposes them in particular to the risk of hemorrhagic complications.
Read more
Number of subjects required:
According to the literature and data collected Louis Mourier in the recent years, the inclusion of 200 patients would examine 20-40 patients with severe histological steatosis and steatohepatitis. All patients will be included in Louis Mourier hospital.
Follow-up: one month Search duration: 37 months Duration inclusions: 36 months The total duration of participation for a patient will be one month.
Methodology:
It is a monocentric, prospective study evaluating the value of noninvasive tests for the diagnosis of hepatic lesions in morbid obese patients. The "open " MRI system allows access to MRI for all obese patients (maximum weight 250 kg). Three of such systems are available in France and liver pathology can be explored only on the system of Louis Mourier.
The reference method is liver histology; studied tests are abdominal MRI, Fibroscan / CAP, and serum tests.
Examinations required specifically for research Examinations required specifically for the research is abdominal MRI, FibroScan/ CAP and serum tests.
Primary endpoint :
To validate the use of abdominal MRI, the FibroScan/ CAP and serum tests for finding severe steatosis and / or NASH, specificity, sensitivity, positive and negative predictive values of these tests are calculated. The gold standard is the result of histology on liver biopsy, with a morphometric study of these parameters. ROC curves are used to determine the best compromise between sensitivity and specificity.
The secondary endpoints were:
Histological lesions of liver fibrosis. Quantification of abdominal fat by MRI (in the form of three variables of interest: quantification of the surface of the visceral fat, of subcutaneous fat and of intrahepatic fat assessed by the percentage loss of signal
Read the detailed description
Main objective :
The main objective of the study was to determine in patients with morbid obesity waiting for bariatric surgery, the accuracy of non-invasive tests for diagnosis of severe steatosis and / or NASH.
The gold standard is liver biopsy with a morphometric study.
Non-invasive tests will be used:
- Serum tests: the FibroMax (which includes the NASH test, FibroTest and SteatoTest) and FibroMeter.
- Radiological examinations: MRI and FibroScan / CAP
Secondary objectives :
The secondary objectives are:
- to determine the accuracy of these non-invasive tests for the diagnosis of severe steatosis alone, steatohepatitis (NASH or) and hepatic fibrosis
- to determine the best combination of these tests to better evaluate the presence of severe steatosis, NASH and a hepatic fibrosis.
- to quantify MRI visceral and subcutaneous fat in morbidly obese patients
Research Design :
- Judging Criteria Primary endpoint To validate the use of serum tests, FibroScan / CAP abdominal MRI for the diagnosis of severe steatosis and / or NASH (specificity, sensitivity, positive and negative predictive values). The gold standard is the result of histology on liver biopsy, with a morphometric study. For each diagnostic test, a ROC curve is used to determine the best compromise between sensitivity and specificity. The histological diagnosis of severe steatosis is defined by the presence of hepatic steatosis grade 3 or higher. The diagnosis of NASH is defined by the presence of lobular inflammation with neutrophils and hepatocytes ballooning. Secondary endpoints
- Histological lesions of liver fibrosis Quantification of abdominal fat by MRI (in the form of three variables of interest: quantification of the surface of the visceral fat from the surface of the subcutaneous fat and the amount of intrahepatic fat assessed by the percentage loss of signal).
- Methodology and expected number of patients in research This is a prospective study evaluating the value of noninvasive tests for the diagnosis of hepatic lesions in morbid obese patients. The MRI system "open" allows access to obese patients. Three such systems are available in France and liver pathology is supported only on the system of Louis Mourier. The reference method is liver histology; tests studied are MRI abdominal Fibroscan / CAP, and serum tests (FibroTest, FibroMeter, SteatoTest, NASH test). The study will be conducted in 200 obese patients who will have a liver biopsy performed during bariatric surgery:
- Tests for the detection of steatosis (fat quantification of intrahepatic MRI measurement of steatosis by CAP, serum tests) and evaluating histological steatosis (main objective)
- Tests for the detection of NASH (test serum) and histology
- Tests of fibrosis (serum tests; FibroScan) and histological data assessing fibrosis. The duration and extent of obesity (BMI) and biological data (HOMA-test) will be taken into account.
- Examinations required specifically for research Liver biopsy is routinely performed intraoperatively in the routine monitoring of patients for bariatric surgery, examinations specific to the research are:
- Serum tests
- FibroScan / CAP
- Abdominal MRI Risk / risk absences The sting at blood sampling can cause the formation of a small hematoma without gravity, which will subside spontaneously within a few days. FibroScan ® / CAP presents no risk of side effects. Liver MRI shows no risk if the cons-indications are respected. Wearing a stack (pacemaker) or any element that contains the iron near the eyes or head are contra-indications as are a major risk factor (risk of death, blindness). The presence of a heart valve or a stent (also called metal prosthesis) is not an absolute contra-indication-and their compatibility with MRI will be verified before completion of the examination, as is the case in practice clinic .. Liver biopsy, which is part of the examinations carried out in a systematic way without any protocol adds no additional risk to the surgical
- Study site The study will be conducted at Louis Mourier, a reference center for the treatment of obesity, which has an open system allowing access to obese.
- Indications for bariatric surgery
Indications for bariatric surgery at Louis Mourier, a reference center for the treatment of obesity, are consistent with the recommendations of the HAS in 2009, based on professional consensus.
Surgery is indicated in patients with all of the following criteria:
- BMI ≥ 40 or BMI ≥ 35 with comorbid
- failure (s) prior (s) of the conventional treatment of obesity combined dietary, physical activity and behavioral therapy
- appraisal nutritionally: global, personal and non-surgical
- considered only after medical treatment for a minimum of 1 year
- well-informed and motivated patients, with acceptable surgical risks
- obesity stable (or worsening) for five years
- absence of endocrine pathology (adrenal, thyroid) may be due to obesity
- Conditions
- Morbid Obesity, Non Alcoholic Steatohepatitis
- Keywords
- Non alcoholic steatohepatitis, Liver fibrosis,Steatosis, Liver inflammation, Morbid obesity, Non invasive tests
- Medical subject headings
- Obesity, Morbid, Non-alcoholic Fatty Liver Disease, Liver Cirrhosis, Fatty Liver, Hepatitis
What is being measured
The primary outcome is the main question the study is designed to answer.
To validate the use of serum tests, FibroScan / CAP abdominal MRI for the diagnosis of severe steatosis and / or NASH (specificity, sensitivity, positive and negative predictive values)
serum tests, FibroScan/CAP abdominal MRI
Measured: 3 months
Secondary outcomes (1)
Histological lesions of liver fibrosis and quantification of abdominal fat by MRI
quantification of abdominal fat by MRI in the form of three variables of interest: quantification of the surface of the visceral fat from the surface of the subcutaneous fat and the amount of intrahepatic fat assessed by the percentage loss of signal
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pauline Jouët, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01695083
- Sponsor's protocol ID
- P091119
- Other IDs
- 2011-A00829-32
- Acronym
- FIRM
- Status last verified
- Sep 2016
- First submitted
- 25 Sep 2012
- Last updated
- 19 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Invasive Measurements of Fibrosis, Inflammation and Steatohepatitis in Morbidly Obese Patients
- ClinicalTrials.gov ID
- NCT01695083
- Acronym / sponsor ID
- FIRM / P091119
- Conditions
- Morbid Obesity, Non Alcoholic Steatohepatitis
- Keywords
- Non alcoholic steatohepatitis, Liver fibrosis,Steatosis, Liver inflammation, Morbid obesity, Non invasive tests
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 27 Sep 2012 (estimated)
- 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.
Abstract:
Fatty liver most frequently corresponds to a fat overload of the liver. It is usually classified as alcoholic steatosis or non-alcoholic steatosis. In the case of non alcoholic fatty liver overload, the histological spectrum ranges from simple steatosis to steatohepatitis (NASH) which associates inflammation to steatosis, with a risk of progression to fibrosis and cirrhosis. Obese patients are at particular risk of NASH. Screening of these hepatic lesions is difficult especially as they may exist while the liver tests are normal. The diagnosis of NASH is currently done by liver biopsy, which exposes them in particular to the risk of hemorrhagic complications.
Number of subjects required:
According to the literature and data collected Louis Mourier in the recent years, the inclusion of 200 patients would examine 20-40 patients with severe histological steatosis and steatohepatitis. All patients will be included in Louis Mourier hospital.
Follow-up: one month Search duration: 37 months Duration inclusions: 36 months The total duration of participation for a patient will be one month.
Methodology:
It is a monocentric, prospective study evaluating the value of noninvasive tests for the diagnosis of hepatic lesions in morbid obese patients. The "open " MRI system allows access to MRI for all obese patients (maximum weight 250 kg). Three of such systems are available in France and liver pathology can be explored only on the system of Louis Mourier.
The reference method is liver histology; studied tests are abdominal MRI, Fibroscan / CAP, and serum tests.
Examinations required specifically for research Examinations required specifically for the research is abdominal MRI, FibroScan/ CAP and serum tests.
Primary endpoint :
To validate the use of abdominal MRI, the FibroScan/ CAP and serum tests for finding severe steatosis and / or NASH, specificity, sensitivity, positive and negative predictive values of these tests are calculated. The gold standard is the result of histology on liver biopsy, with a morphometric study of these parameters. ROC curves are used to determine the best compromise between sensitivity and specificity.
The secondary endpoints were:
Histological lesions of liver fibrosis. Quantification of abdominal fat by MRI (in the form of three variables of interest: quantification of the surface of the visceral fat, of subcutaneous fat and of intrahepatic fat assessed by the percentage loss of signal
Detailed description
Main objective :
The main objective of the study was to determine in patients with morbid obesity waiting for bariatric surgery, the accuracy of non-invasive tests for diagnosis of severe steatosis and / or NASH.
The gold standard is liver biopsy with a morphometric study.
Non-invasive tests will be used:
- Serum tests: the FibroMax (which includes the NASH test, FibroTest and SteatoTest) and FibroMeter.
- Radiological examinations: MRI and FibroScan / CAP
Secondary objectives :
The secondary objectives are:
- to determine the accuracy of these non-invasive tests for the diagnosis of severe steatosis alone, steatohepatitis (NASH or) and hepatic fibrosis
- to determine the best combination of these tests to better evaluate the presence of severe steatosis, NASH and a hepatic fibrosis.
- to quantify MRI visceral and subcutaneous fat in morbidly obese patients
Research Design :
- Judging Criteria Primary endpoint To validate the use of serum tests, FibroScan / CAP abdominal MRI for the diagnosis of severe steatosis and / or NASH (specificity, sensitivity, positive and negative predictive values). The gold standard is the result of histology on liver biopsy, with a morphometric study. For each diagnostic test, a ROC curve is used to determine the best compromise between sensitivity and specificity. The histological diagnosis of severe steatosis is defined by the presence of hepatic steatosis grade 3 or higher. The diagnosis of NASH is defined by the presence of lobular inflammation with neutrophils and hepatocytes ballooning. Secondary endpoints
- Histological lesions of liver fibrosis Quantification of abdominal fat by MRI (in the form of three variables of interest: quantification of the surface of the visceral fat from the surface of the subcutaneous fat and the amount of intrahepatic fat assessed by the percentage loss of signal).
- Methodology and expected number of patients in research This is a prospective study evaluating the value of noninvasive tests for the diagnosis of hepatic lesions in morbid obese patients. The MRI system "open" allows access to obese patients. Three such systems are available in France and liver pathology is supported only on the system of Louis Mourier. The reference method is liver histology; tests studied are MRI abdominal Fibroscan / CAP, and serum tests (FibroTest, FibroMeter, SteatoTest, NASH test). The study will be conducted in 200 obese patients who will have a liver biopsy performed during bariatric surgery:
- Tests for the detection of steatosis (fat quantification of intrahepatic MRI measurement of steatosis by CAP, serum tests) and evaluating histological steatosis (main objective)
- Tests for the detection of NASH (test serum) and histology
- Tests of fibrosis (serum tests; FibroScan) and histological data assessing fibrosis. The duration and extent of obesity (BMI) and biological data (HOMA-test) will be taken into account.
- Examinations required specifically for research Liver biopsy is routinely performed intraoperatively in the routine monitoring of patients for bariatric surgery, examinations specific to the research are:
- Serum tests
- FibroScan / CAP
- Abdominal MRI Risk / risk absences The sting at blood sampling can cause the formation of a small hematoma without gravity, which will subside spontaneously within a few days. FibroScan ® / CAP presents no risk of side effects. Liver MRI shows no risk if the cons-indications are respected. Wearing a stack (pacemaker) or any element that contains the iron near the eyes or head are contra-indications as are a major risk factor (risk of death, blindness). The presence of a heart valve or a stent (also called metal prosthesis) is not an absolute contra-indication-and their compatibility with MRI will be verified before completion of the examination, as is the case in practice clinic .. Liver biopsy, which is part of the examinations carried out in a systematic way without any protocol adds no additional risk to the surgical
- Study site The study will be conducted at Louis Mourier, a reference center for the treatment of obesity, which has an open system allowing access to obese.
- Indications for bariatric surgery
Indications for bariatric surgery at Louis Mourier, a reference center for the treatment of obesity, are consistent with the recommendations of the HAS in 2009, based on professional consensus.
Surgery is indicated in patients with all of the following criteria:
- BMI ≥ 40 or BMI ≥ 35 with comorbid
- failure (s) prior (s) of the conventional treatment of obesity combined dietary, physical activity and behavioral therapy
- appraisal nutritionally: global, personal and non-surgical
- considered only after medical treatment for a minimum of 1 year
- well-informed and motivated patients, with acceptable surgical risks
- obesity stable (or worsening) for five years
- absence of endocrine pathology (adrenal, thyroid) may be due to obesity
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- morbidly obese patients undergoing bariatric surgery
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- BMI ≥ 35 kg/m2
- Bariatric surgery scheduled within 3 months following the inclusion
- Conducting a medical examination.
- Signature of informed consent
Key exclusion criteria (8 listed)
- Patient non-affiliated to a social security scheme (beneficiary or assignee)
- Cons-indication for performing an MRI
- weight> 230 kg , anteroposterior diameter>40 cm
- Cancer treatment or medication that may induce lesions of steatohepatitis (corticoids, methotrexate, amiodarone, perhexiline, tamoxifen, nifedipine, diltiazem, hycanthone)
- Alcohol consumption > 20 g per day for women and > 30 g per day for men AND no past history of excessive alcohol use for more than a 2-year period within the last 20 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To validate the use of serum tests, FibroScan / CAP abdominal MRI for the diagnosis of severe steatosis and / or NASH (specificity, sensitivity, positive and negative predictive values)
Time frame: 3 months
serum tests, FibroScan/CAP abdominal MRI
1 secondary outcome
Histological lesions of liver fibrosis and quantification of abdominal fat by MRI
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2019.
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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.
Pauline Jouët, MD principal investigator
Assistance Publique - Hôpitaux de Paris
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 Morbid Obesity and Non Alcoholic Steatohepatitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 5 inclusion and 8 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 19 Dec 2019. 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 France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To validate the use of serum tests, FibroScan / CAP abdominal MRI for the diagnosis of severe steatosis and / or NASH (specificity, sensitivity, positive and negative predictive values) (time frame: 3 months). 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 19 Dec 2019.