Mitochondrial Metabolism and Hepatic Complications of Obe... | NCT03302481

Studies
Mitochondrial Metabolism and Hepatic Complications of Obesity

NCT03302481

Sponsor

Nantes University Hospital

Status

Withdrawn

Last Update Posted

Jun 24, 2026Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Obesity

Interventions

liver biopsy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

no ethic committee autorization

Expanded Access Info

Start Date

Jan 2017Actual

Primary Completion Date

Jan 2017Actual

Completion Date

Jan 2017Actual

First Submitted Date

Oct 2, 2017

First Submission Date that Met QC Criteria

Oct 4, 2017

First Posted Date

Oct 5, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2026

Last Update Posted Date

Jun 24, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
liver biopsy	Other	the biopsies will be performed under laparoscopy and taken in the lower part of the right hepatic lobe	Experimental Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Association between nonalcoholic steato-hepatitis and mitochondria morphological markers		Until 6 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David JACOBI, Dr	Nantes University Hospital	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D005234	Fatty Liver

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided