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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03302481
Other study ID # RC17_0055
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date January 2017
Est. completion date January 2017

Study information

Verified date August 2021
Source Nantes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study aims to characterize mitochondrial metabolism in the liver of obesity surgery patients and to study its relationships with hepatic steatosis, inflammation, and fibrosis.


Description:

The study aims to characterize mitochondrial metabolism in the liver of obesity surgery patients and to study its relationships with hepatic steatosis, inflammation, and fibrosis. The protocols involves a per-operative hepatic needle biopsy for mitochondria characterization and histological scoring of steatosis, inflammation, and fibrosis


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date January 2017
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - adult men and women - affiliated to a social security - candidate for laparoscopic obesity surgery Exclusion Criteria: - Excessive alcohol consumption:> 20 g / day (woman),> 30 g / day (male) - Chronic viral hepatitis B or C - Genetic hemochromatosis - Taking the following drugs for at least 3 months up to 6 months before the scheduled date of obesity surgery: systemic corticosteroids, amiodarone, methotrexate - Wilson's disease - autoimmune hepatitis - alpha 1-antitrypsin deficiency - abetalipoproteinemia - Contraindications to liver biopsy

Study Design


Related Conditions & MeSH terms


Intervention

Other:
liver biopsy
the biopsies will be performed under laparoscopy and taken in the lower part of the right hepatic lobe

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Nantes University Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Association between nonalcoholic steato-hepatitis and mitochondria morphological markers Until 6 month
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