ObesityDMSONCT03302481
Mitochondrial Metabolism and Hepatic Complications of Obesity
A study testing liver biopsy in people with Obesity, run by Nantes University Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- liver biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult men and women
- affiliated to a social security
- candidate for laparoscopic obesity surgery
Who cannot join
- 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
Show all 9Show fewer
- alpha 1-antitrypsin deficiency
- abetalipoproteinemia
- Contraindications to liver biopsy
About this study
Official title: Prospective Physiopathology Study of the Links Between Mitochondrial Dynamics and Fatty Liver Disease During Obesity
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.
Read the 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
- Conditions
- Obesity
- Being tested
- liver biopsy
- Keywords
- Obesity surgery, liver, mitochondria, steatosis
- Medical subject headings
- Obesity, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liver biopsyOther
the biopsies will be performed under laparoscopy and taken in the lower part of the right hepatic lobe
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | the biopsies will be performed under laparoscopy and taken in the lower part of the right hepatic lobe Receives: Other: liver biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between nonalcoholic steato-hepatitis and mitochondria morphological markers
Measured: Until 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2017
- Study startJan 2017
- Primary completionJan 2017
- Study completionJan 2017
Why it stopped: no ethic committee autorization
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David JACOBI, Dr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03302481
- Sponsor's protocol ID
- RC17_0055
- Acronym
- DMSO
- Status last verified
- Aug 2021
- First submitted
- 2 Oct 2017
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Physiopathology Study of the Links Between Mitochondrial Dynamics and Fatty Liver Disease During Obesity
- ClinicalTrials.gov ID
- NCT03302481
- Acronym / sponsor ID
- DMSO / RC17_0055
- Conditions
- Obesity
- Keywords
- Obesity surgery, liver, mitochondria, steatosis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no ethic committee autorization
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 5 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- patients with obesity surgery with a laparoscopic approach scheduled in the department of digestive surgery of the CHU de Nantes
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: liver biopsythe biopsies will be performed under laparoscopy and taken in the lower part of the right hepatic lobe |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult men and women
- affiliated to a social security
- candidate for laparoscopic obesity surgery
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liver biopsythe biopsies will be performed under laparoscopy and taken in the lower part of the right hepatic lobe | Other | Experimental Group |
Primary outcome
Association between nonalcoholic steato-hepatitis and mitochondria morphological markers
Time frame: Until 6 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David JACOBI, Dr principal investigator
Nantes University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing liver biopsy in people with Obesity, run by Nantes University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between nonalcoholic steato-hepatitis and mitochondria morphological markers (time frame: Until 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.