We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Non Invasive Measurements of Fibrosis, Inflammation and Steatohepatitis in Morbidly Obese Patients (FIRM)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01695083
First Posted: September 27, 2012
Last Update Posted: June 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  Purpose

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


Condition
Morbid Obesity Non Alcoholic Steatohepatitis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Non Invasive Measurements of Fibrosis, Inflammation and Steatohepatitis in Morbidly Obese Patients

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Histological lesions of liver fibrosis and quantification of abdominal fat by MRI [ Time Frame: 3 months ]
    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


Biospecimen Retention:   Samples Without DNA
blood, liver biopsy

Enrollment: 180
Study Start Date: October 2012
Study Completion Date: November 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
morbidly obese patients undergoing bariatric surgery
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • BMI ≥ 35 kg/m2
  • Bariatric surgery scheduled within 3 months following the inclusion
  • Conducting a medical examination.
  • Signature of informed consent

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01695083


Locations
France
Hôpital Louis Mourier
Colombes, France, 92700
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Pauline Jouët, MD Assistance Publique - Hôpitaux de Paris
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01695083     History of Changes
Other Study ID Numbers: P091119
2011-A00829-32 ( Registry Identifier: ANSM )
First Submitted: September 25, 2012
First Posted: September 27, 2012
Last Update Posted: June 1, 2017
Last Verified: September 2016

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Non alcoholic steatohepatitis
Liver fibrosis,Steatosis
Liver inflammation
Morbid obesity
Non invasive tests

Additional relevant MeSH terms:
Fibrosis
Inflammation
Fatty Liver
Obesity, Morbid
Non-alcoholic Fatty Liver Disease
Pathologic Processes
Liver Diseases
Digestive System Diseases
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms