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

Obesity Clinical Trial

— IRM Stéatose  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02085876
• Other study ID #: HAMZA APJ 2013
• Status: Not yet recruiting
• Phase: N/A
• First received: March 5, 2014
• Last updated: March 12, 2014

Study information

• Verified date: July 2013
• Source: Centre Hospitalier Universitaire Dijon
• Contact: Samia HAMZA
• Phone: 3 80 29 37 50
• Email: samia.hamza[@]chu-dijon.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Obesity
• Overweight
• Type 2 Diabetes

Intervention

Other:
• 2 additional MRI sequences

• An additional blood sample

Locations

Country	Name	City	State
France	CHU de DIJON	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine a correlation coefficient > 0.80, alpha 0.05 and beta 0.20 between the MRI markers relevant.		Baselines	No
Secondary	To determine the correlation between the unsaturated fat measurements and MRI Lipidomics Spectro analysis.		Baselines	No