Digestive Organs--CancerOxMiTiAdNCT05417581
Mitochondrial Oxygraphy on Subcutaneous and Peri-visceral Adipose Tissue: Influence of Body Composition
A study testing adipose surgery in people with Digestive Organs--Cancer and Bariatric Surgery Candidate, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The objective of this study is to adapt the oxygraphy technique on human adipocytes and to characterize respiration measurements according to patients' body mass index and white adipose tissue localization (subcutaneous vs visceral). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Digestive Organs--Cancer, Bariatric Surgery Candidate, Parietal Region Trauma
- What is being tested?
- adipose surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteFrance
- Study dates
- 14 Apr 2021to 12 Apr 2023
- 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
- Patients undergoing oncological, bariatric, parietal surgery
- Patients able to give an informed consent
- Patients affiliated to an Health Care insurance
- Patients aged over 18
Who cannot join
- Patients under guardianship, curatorship or deprived of freedom
- Pregnant or breastfeeding women
- Participation refusal
- Patients under chemotherapy
- Patients with peritonitis and infectious parietal processes
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to adapt the oxygraphy technique on human adipocytes and to characterize respiration measurements according to patients' body mass index and white adipose tissue localization (subcutaneous vs visceral).
Read the detailed description
During digestive surgery: oncological and bariatric surgery, it is possible to collect a small volume of subcutaneous and epiplonic adipose tissue (10-20 cc). We wish to collect these samples in order to develop the technique of oxygenography on permeabilized adipocytes. In order to characterize these measurements, they will be related to the clinical data of the patients usually collected in the framework of the preoperative assessment including the body mass index (BMI). The measured adipocyte data will thus be normalized to three BMI classes: ≤ 20, > to 20 < 30, and ≥ to 30 kg∙m-2.
Primary end point is to validate the measurement of mitochondrial respiration under oxidophosphorylating conditions by determining indicators of the distribution of mitochondrial respiration values (mean, standard deviation, skewness, kurtosis, coefficient of variation) as a function of patients' body mass index.
- Being tested
- adipose surgery
- Keywords
- Mitochondria, Oxygraphy, Adipose Tissue, Body Mass Index, Digestive surgery
- Medical subject headings
- Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adipose surgeryProcedure or surgery
A quantity of adipose tissue equivalent to 10-20 cubic centimeter will be removed subcutaneously and from the omentum during surgical procedures (oncological, bariatric)
| Study group | Role | What they receive |
|---|---|---|
| All patients | Experimental | a sample of adipose tissue will be collected during the scheduled surgery Receives: Procedure: adipose surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of mitochondrial respiration on adipose tissue by oxygraphy
Mitochondrial respiration measurements in oxydophosphorylated conditions. For each patient measurements using ADP and carbohydrate or lipid substrates of the respiratory chain complexes for both the subcutaneous and the visceral tissue.
Measured: day 1
Secondary outcomes (3)
mitochondrial respiration values depending on patients BMI by oxygraphy
Identification of mitochondrial respiration discrimination factors
Measured: day 1
comparing mitochondrial respiration values depending on tissue location by oxygraphy
Identification of mitochondrial respiration discrimination factors
Measured: day 1
comparing mitochondrial respiration values depending on anthropometric data by oxygraphy
Identification of mitochondrial respiration discrimination factors
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start14 Apr 2021
- Primary completion12 Apr 2023
- Study completion12 Apr 2023
Why it stopped: Difficulty of recruitment for Groups 1 and 3 not allowing all recruitment to be carried out over a reasonable period of time, it was decided to close this project
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Digestive Organs--CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- all participants receive the same intervention
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ruddy RICHARD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05417581
- Sponsor's protocol ID
- RBHP 2020 RICHARD
- Other IDs
- 2020-A03309-30
- Acronym
- OxMiTiAd
- Status last verified
- Aug 2026
- First submitted
- 17 May 2022
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guerrier L, Bacoeur-Ouzillou O, Touron J, Mezher S, Cassagnes L, Vieille-Marchiset A, Chanon S, Pereira B, Pezet D, Pinel A, Gagniere J, Malpuech-Brugere C, Richard R. Mitochondrial respiration in white adipose tissue is dependent on body mass index and tissue location in patients undergoing oncological or parietal digestive surgery. FASEB J. 2025 Jan 31;39(2):e70350. doi: 10.1096/fj.202402243R.
PubMed 39856788
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitochondrial Oxygraphy on Subcutaneous and Peri-visceral Adipose Tissue: Influence of Body Composition
- ClinicalTrials.gov ID
- NCT05417581
- Acronym / sponsor ID
- OxMiTiAd / RBHP 2020 RICHARD
- Keywords
- Mitochondria, Oxygraphy, Adipose Tissue, Body Mass Index, Digestive surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty of recruitment for Groups 1 and 3 not allowing all recruitment to be carried out over a reasonable period of time, it was decided to close this project
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 12 Apr 2023 (actual)
- Study completion
- 12 Apr 2023 (actual)
- First posted
- 14 Jun 2022 (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 objective of this study is to adapt the oxygraphy technique on human adipocytes and to characterize respiration measurements according to patients' body mass index and white adipose tissue localization (subcutaneous vs visceral).
Detailed description
During digestive surgery: oncological and bariatric surgery, it is possible to collect a small volume of subcutaneous and epiplonic adipose tissue (10-20 cc). We wish to collect these samples in order to develop the technique of oxygenography on permeabilized adipocytes. In order to characterize these measurements, they will be related to the clinical data of the patients usually collected in the framework of the preoperative assessment including the body mass index (BMI). The measured adipocyte data will thus be normalized to three BMI classes: ≤ 20, > to 20 < 30, and ≥ to 30 kg∙m-2.
Primary end point is to validate the measurement of mitochondrial respiration under oxidophosphorylating conditions by determining indicators of the distribution of mitochondrial respiration values (mean, standard deviation, skewness, kurtosis, coefficient of variation) as a function of patients' body mass index.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- all participants receive the same intervention
| Arm | Type | Receives |
|---|---|---|
| All patients | Experimental | Procedure: adipose surgerya sample of adipose tissue will be collected during the scheduled surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing oncological, bariatric, parietal surgery
- Patients able to give an informed consent
- Patients affiliated to an Health Care insurance
- Patients aged over 18
Key exclusion criteria (5 listed)
- Patients under guardianship, curatorship or deprived of freedom
- Pregnant or breastfeeding women
- Participation refusal
- Patients under chemotherapy
- Patients with peritonitis and infectious parietal processes
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 |
|---|---|---|
| adipose surgeryA quantity of adipose tissue equivalent to 10-20 cubic centimeter will be removed subcutaneously and from the omentum during surgical procedures (oncological, bariatric) | Procedure or surgery | All patients |
Primary outcome
Evaluation of mitochondrial respiration on adipose tissue by oxygraphy
Time frame: day 1
Mitochondrial respiration measurements in oxydophosphorylated conditions. For each patient measurements using ADP and carbohydrate or lipid substrates of the respiratory chain complexes for both the subcutaneous and the visceral tissue.
3 secondary outcomes
mitochondrial respiration values depending on patients BMI by oxygraphy
Time frame: day 1
comparing mitochondrial respiration values depending on tissue location by oxygraphy
Time frame: day 1
comparing mitochondrial respiration values depending on anthropometric data by oxygraphy
Time frame: day 1
Results and safety
The study was stopped early (reason given: Difficulty of recruitment for Groups 1 and 3 not allowing all recruitment to be carried out over a reasonable period of time, it was decided to close this project). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Results publication: PubMed 39856788Guerrier L, Bacoeur-Ouzillou O, Touron J, Mezher S, Cassagnes L, Vieille-Marchiset A, Chanon S, Pereira B, Pezet D, Pinel A, Gagniere J, Malpuech-Brugere C, Richard R. Mitochondrial respiration in white adipose tissue is dependent on body mass index and tissue location in patients undergoing oncological or parietal digestive surgery. FASEB J. 2025 Jan 31;39(2):e70350. doi: 10.1096/fj.202402243R.
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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.
Ruddy RICHARD principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing adipose surgery in people with Digestive Organs--Cancer and Bariatric Surgery Candidate, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 stopped early (reason given: Difficulty of recruitment for Groups 1 and 3 not allowing all recruitment to be carried out over a reasonable period of time, it was decided to close this project). Results are not available in the source record.
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?
Evaluation of mitochondrial respiration on adipose tissue by oxygraphy (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05417581, which also lists 1 linked publication.
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 7 Aug 2026.