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

Sponsor

Centre Hospitalier Universitaire Dijon (Other)

Overall Status

Unknown status

CT.gov ID

NCT02085876

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

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	Phase
Overweight Type 2 Diabetes Obesity	Other: 2 additional MRI sequences Other: An additional blood sample

Study Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Anticipated Primary Completion Date :

Feb 1, 2016

Arms and Interventions

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

Arm

Intervention/Treatment

Patients requiring a liver biopsy

Other: 2 additional MRI sequences

Other: An additional blood sample

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

To determine the correlation between the unsaturated fat measurements and MRI Lipidomics Spectro analysis. [Baselines]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	CHU de DIJON	Dijon		France	21079

Sponsors and Collaborators

Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire Dijon

ClinicalTrials.gov Identifier:

NCT02085876

Other Study ID Numbers:

HAMZA APJ 2013

First Posted:

Mar 13, 2014

Last Update Posted:

Mar 13, 2014

Last Verified:

Jul 1, 2013

Keywords provided by Centre Hospitalier Universitaire Dijon

patients

present

undergo bariatric surgery

Additional relevant MeSH terms:

Overweight

Study Results

No Results Posted as of Mar 13, 2014