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Quantitative and Qualitative MRI Study of Steatosis in Patients With Metabolic Steatopathy (IRM Stéatose)

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.
 
ClinicalTrials.gov Identifier: NCT02085876
Recruitment Status : Unknown
Verified July 2013 by Centre Hospitalier Universitaire Dijon.
Recruitment status was:  Not yet recruiting
First Posted : March 13, 2014
Last Update Posted : March 13, 2014
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Study Description
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Brief Summary:

This is a single centre prospective open-label, non-randomised pilot study whose aim is to identify MRI parameters to better evaluate inflammation and liver fibrosis and thus, in the near future, to avoid the need for liver biopsy.

To achieve this:

  • The MRI study will be completed by adding two sequences: Measurement of T1 and multiecho T2*. The other data will be extracted from usual sequences.
  • Part of the histological samples will be used for the weighted levels of fat and iron, and for the lipidomic study.
  • Usual blood samples will be completed by samples for the serum library

Condition or disease Intervention/treatment
Overweight Type 2 Diabetes Obesity Other: 2 additional MRI sequences Other: An additional blood sample

Study Design
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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Quantitative and Qualitative MRI Study of Steatosis in Patients With Metabolic Steatopathy
Estimated Primary Completion Date : February 2016

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients requiring a liver biopsy Other: 2 additional MRI sequences
Other: An additional blood sample


Outcome Measures
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Primary Outcome Measures :
  1. To determine a correlation coefficient > 0.80, alpha 0.05 and beta 0.20 between the MRI markers relevant. [ Time Frame: Baselines ]

Secondary Outcome Measures :
  1. To determine the correlation between the unsaturated fat measurements and MRI Lipidomics Spectro analysis. [ Time Frame: Baselines ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Overweight patients or patients with type 2 diabetes or obese patients (who present a liver anomaly and should undergo bariatric surgery)
Criteria

Inclusion Criteria:

  • Patients who have been informed about the research
  • Patients with national health insurance cover
  • Patients who are overweight (BMI > 25) or have type 2 diabetes suggesting a disturbance of hepatic enzymes (ASAT < 8 times normal values and ALAT > twice normal values) after a complete hepatopathy assessment
  • Obese patients with a hepatic anomaly (steatosis) revealed by imaging or biological assessment (ASAT < 8 times normal values and ALAT > twice normal values) who are eligible for bariatric surgery and a preoperative liver MRI examination.

Exclusion Criteria:

  • Non-corrected coagulation disorder.
  • Patients aged over 80 years
  • Patients aged less than 18 years
  • Patients without legal protection
  • Patients with a contra-indication for MRI (Pacemaker, intraocular metallic foreign body, weight>150kg)
  • Patients without national health insurance cover
Contacts and Locations
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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): NCT02085876


Contacts
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Contact: Samia HAMZA 3 80 29 37 50 ext +33 samia.hamza@chu-dijon.fr

Locations
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France
CHU de DIJON
Dijon, France, 21079
Contact: Samia HAMZA    3 80 29 37 50 ext +33    samia.hamza@chu-dijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
More Information
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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT02085876    
Other Study ID Numbers: HAMZA APJ 2013
First Posted: March 13, 2014    Key Record Dates
Last Update Posted: March 13, 2014
Last Verified: July 2013
Keywords provided by Centre Hospitalier Universitaire Dijon:
patients
present
undergo bariatric surgery
Additional relevant MeSH terms:
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Overweight
Body Weight