Mitochondrial Oxygraphy on Subcutaneous and Peri-visceral Adipose Tissue: Influence of Body Composition (OxMiTiAd)
Primary Purpose
Digestive Organs--Cancer, Bariatric Surgery Candidate, Parietal Region Trauma
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
adipose surgery
Sponsored by
About this trial
This is an interventional health services research trial for Digestive Organs--Cancer focused on measuring Mitochondria, Oxygraphy, Adipose Tissue, Body Mass Index, Digestive surgery
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing oncological, bariatric, parietal surgery
- Patients able to give an informed consent
- Patients affiliated to an Health Care insurance
- Patients aged over 18
Exclusion Criteria:
- Patients under guardianship, curatorship or deprived of freedom
- Pregnant or breastfeeding women
- Participation refusal
- Patients under chemotherapy
- Patients with peritonitis and infectious parietal processes
Sites / Locations
- CHU clermont-ferrand
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
All patients
Arm Description
a sample of adipose tissue will be collected during the scheduled surgery
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
mitochondrial respiration values depending on patients BMI by oxygraphy
Identification of mitochondrial respiration discrimination factors
comparing mitochondrial respiration values depending on tissue location by oxygraphy
Identification of mitochondrial respiration discrimination factors
comparing mitochondrial respiration values depending on anthropometric data by oxygraphy
Identification of mitochondrial respiration discrimination factors
Full Information
NCT ID
NCT05417581
First Posted
May 17, 2022
Last Updated
September 29, 2023
Sponsor
University Hospital, Clermont-Ferrand
1. Study Identification
Unique Protocol Identification Number
NCT05417581
Brief Title
Mitochondrial Oxygraphy on Subcutaneous and Peri-visceral Adipose Tissue: Influence of Body Composition
Acronym
OxMiTiAd
Official Title
Mitochondrial Oxygraphy on Subcutaneous and Peri-visceral Adipose Tissue: Influence of Body Composition
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why 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
Study Start Date
April 14, 2021 (Actual)
Primary Completion Date
April 12, 2023 (Actual)
Study Completion Date
April 12, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Digestive Organs--Cancer, Bariatric Surgery Candidate, Parietal Region Trauma
Keywords
Mitochondria, Oxygraphy, Adipose Tissue, Body Mass Index, Digestive surgery
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
all participants receive the same intervention
Masking
None (Open Label)
Allocation
N/A
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
All patients
Arm Type
Experimental
Arm Description
a sample of adipose tissue will be collected during the scheduled surgery
Intervention Type
Procedure
Intervention Name(s)
adipose surgery
Intervention Description
A quantity of adipose tissue equivalent to 10-20 cubic centimeter will be removed subcutaneously and from the omentum during surgical procedures (oncological, bariatric)
Primary Outcome Measure Information:
Title
Evaluation of mitochondrial respiration on adipose tissue by oxygraphy
Description
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.
Time Frame
day 1
Secondary Outcome Measure Information:
Title
mitochondrial respiration values depending on patients BMI by oxygraphy
Description
Identification of mitochondrial respiration discrimination factors
Time Frame
day 1
Title
comparing mitochondrial respiration values depending on tissue location by oxygraphy
Description
Identification of mitochondrial respiration discrimination factors
Time Frame
day 1
Title
comparing mitochondrial respiration values depending on anthropometric data by oxygraphy
Description
Identification of mitochondrial respiration discrimination factors
Time Frame
day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing oncological, bariatric, parietal surgery
Patients able to give an informed consent
Patients affiliated to an Health Care insurance
Patients aged over 18
Exclusion Criteria:
Patients under guardianship, curatorship or deprived of freedom
Pregnant or breastfeeding women
Participation refusal
Patients under chemotherapy
Patients with peritonitis and infectious parietal processes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruddy RICHARD
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU clermont-ferrand
City
Clermont-Ferrand
Country
France
12. IPD Sharing Statement
Learn more about this trial
Mitochondrial Oxygraphy on Subcutaneous and Peri-visceral Adipose Tissue: Influence of Body Composition
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