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

NCT02085876 | Unknown

• 1 other identifier: HAMZA APJ 2013
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Overweight; Type 2 Diabetes; Obesity

Keywords

patients; present; undergo bariatric surgery

Outcome Measures

Primary Outcomes (1)

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

  Baselines

Secondary Outcomes (1)

• To determine the correlation between the unsaturated fat measurements and MRI Lipidomics Spectro analysis.

  Baselines

Study Arms (1)

Patients requiring a liver biopsy

Other: 2 additional MRI sequences; Other: An additional blood sample

Interventions

2 additional MRI sequences OTHER

Patients requiring a liver biopsy

An additional blood sample OTHER

Patients requiring a liver biopsy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CHU de DIJON

Dijon, 21079, France

Location

MeSH Terms

Conditions

Overweight; Diabetes Mellitus, Type 2; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Samia HAMZA

CONTACT

3 80 29 37 50; samia.hamza@chu-dijon.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2014
• First Posted: March 13, 2014
• Primary Completion: February 1, 2016
• Last Updated: March 13, 2014

Record last verified: 2013-07

Locations

FR (1)