Mitochondrial Metabolism and Hepatic Complications of Obesity

Obesity Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03302481
• Other study ID #: RC17_0055
• Status: Withdrawn
• Phase: N/A
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• Obesity

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