DMSO: Mitochondrial Metabolism and Hepatic Complications of Obesity

Sponsor

Nantes University Hospital (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03302481

Collaborator

(none)

Enrollment

Arm

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Other: liver biopsy	N/A

Detailed 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

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Prospective Physiopathology Study of the Links Between Mitochondrial Dynamics and Fatty Liver Disease During Obesity

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Jan 1, 2017

Actual Study Completion Date :

Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Group the biopsies will be performed under laparoscopy and taken in the lower part of the right hepatic lobe	Other: liver biopsy the biopsies will be performed under laparoscopy and taken in the lower part of the right hepatic lobe

Arm

Intervention/Treatment

Experimental: Experimental Group

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

Other: liver biopsy

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

Outcome Measures

Primary Outcome Measures

Association between nonalcoholic steato-hepatitis and mitochondria morphological markers [Until 6 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Nantes University Hospital

Investigators

Principal Investigator: David JACOBI, Dr, Nantes University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nantes University Hospital

ClinicalTrials.gov Identifier:

NCT03302481

Other Study ID Numbers:

RC17_0055

First Posted:

Oct 5, 2017

Last Update Posted:

Aug 24, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Nantes University Hospital

Additional relevant MeSH terms:

Obesity

Study Results

No Results Posted as of Aug 24, 2021