Mitochondrial Metabolism and Hepatic Complications of Obesity

NCT ID: NCT03302481

Last Updated: 2021-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-01-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

patients with obesity surgery with a laparoscopic approach scheduled in the department of digestive surgery of the CHU de Nantes
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Experimental Group

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

Group Type EXPERIMENTAL

liver biopsy

Intervention Type OTHER

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

Interventions

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liver biopsy

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David JACOBI, Dr

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Other Identifiers

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RC17_0055

Identifier Type: -

Identifier Source: org_study_id

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