Quantitative and Qualitative MRI Study of Steatosis in Patients With Metabolic Steatopathy

• Conditions: Overweight; Type 2 Diabetes; Obesity
• Interventions: Other: 2 additional MRI sequences; Other: An additional blood sample

• Registration Number: NCT02085876
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-07
• Study First Submitted: 2014-03-05
• Study First Submitted QC: 2014-03-12
• Last Update Submitted: 2014-03-12
• Study First Posted: 2014-03-13
• Last Update Posted: 2014-03-13
• Primary Completion: 2016-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients requiring a liver biopsy	2 additional MRI sequences	-
Patients requiring a liver biopsy	An additional blood sample	-

Primary Outcome Measures

Name	Time	Method
To determine a correlation coefficient > 0.80, alpha 0.05 and beta 0.20 between the MRI markers relevant.	Baselines

Secondary Outcome Measures

Name	Time	Method
To determine the correlation between the unsaturated fat measurements and MRI Lipidomics Spectro analysis.	Baselines

Trial Locations

Locations (1)

CHU de DIJON; 🇫🇷 Dijon, France