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Mitochondrial Metabolism and Hepatic Complications of Obesity (DMSO)

Primary Purpose

Obesity

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
liver biopsy
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obesity focused on measuring Obesity surgery, liver, mitochondria, steatosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Experimental Group

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    Association between nonalcoholic steato-hepatitis and mitochondria morphological markers

    Secondary Outcome Measures

    Full Information

    First Posted
    October 2, 2017
    Last Updated
    August 18, 2021
    Sponsor
    Nantes University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03302481
    Brief Title
    Mitochondrial Metabolism and Hepatic Complications of Obesity
    Acronym
    DMSO
    Official Title
    Prospective Physiopathology Study of the Links Between Mitochondrial Dynamics and Fatty Liver Disease During Obesity
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    no ethic committee autorization
    Study Start Date
    January 2017 (Actual)
    Primary Completion Date
    January 2017 (Actual)
    Study Completion Date
    January 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Nantes University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity
    Keywords
    Obesity surgery, liver, mitochondria, steatosis

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    patients with obesity surgery with a laparoscopic approach scheduled in the department of digestive surgery of the CHU de Nantes
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental Group
    Arm Type
    Experimental
    Arm Description
    the biopsies will be performed under laparoscopy and taken in the lower part of the right hepatic lobe
    Intervention Type
    Other
    Intervention Name(s)
    liver biopsy
    Intervention Description
    the biopsies will be performed under laparoscopy and taken in the lower part of the right hepatic lobe
    Primary Outcome Measure Information:
    Title
    Association between nonalcoholic steato-hepatitis and mitochondria morphological markers
    Time Frame
    Until 6 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David JACOBI, Dr
    Organizational Affiliation
    Nantes University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Mitochondrial Metabolism and Hepatic Complications of Obesity

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