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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02085876
Acronym
IRM Stéatose
Enrollment
30
Registered
2014-03-13
Start date
Unknown
Completion date
Unknown
Last updated
2014-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Overweight, Type 2 Diabetes

Keywords

patients, present, undergo bariatric surgery

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

Interventions

OTHER2 additional MRI sequences
OTHERAn additional blood sample

Sponsors

Centre Hospitalier Universitaire Dijon
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
To determine the correlation between the unsaturated fat measurements and MRI Lipidomics Spectro analysis.Baselines

Countries

France

Contacts

Primary ContactSamia HAMZA
samia.hamza@chu-dijon.fr3 80 29 37 50

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026