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

March 12, 2014 updated by: Centre Hospitalier Universitaire Dijon

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients requiring a liver biopsy
Other: 2 additional MRI sequences
Other: An additional blood sample

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine the correlation between the unsaturated fat measurements and MRI Lipidomics Spectro analysis.
Time Frame: Baselines
Baselines

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Anticipated)

February 1, 2016

Study Registration Dates

First Submitted

March 5, 2014

First Submitted That Met QC Criteria

March 12, 2014

First Posted (Estimate)

March 13, 2014

Study Record Updates

Last Update Posted (Estimate)

March 13, 2014

Last Update Submitted That Met QC Criteria

March 12, 2014

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HAMZA APJ 2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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