Mitochondrial Metabolism and Hepatic Complications of Obesity

NCT03302481 | Withdrawn

• 1 other identifier: RC17_0055
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity

Keywords

Obesity surgery; liver; mitochondria; steatosis

Outcome Measures

Primary Outcomes (1)

• Association between nonalcoholic steato-hepatitis and mitochondria morphological markers

  Until 6 month

Study Arms (1)

Experimental Group

EXPERIMENTAL

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

Other: liver biopsy

Interventions

liver biopsy OTHER

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

Experimental Group

Eligibility Criteria

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

You may qualify if:

• adult men and women
• affiliated to a social security
• candidate for laparoscopic obesity surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

MeSH Terms

Conditions

Obesity; Fatty Liver

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases

Study Officials

• David JACOBI, Dr

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: October 5, 2017
• Study Start: January 1, 2017
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: August 24, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share