Mitochondrial Oxygraphy on Subcutaneous and Peri-visceral Adipose Tissue: Influence of Body Composition (OxMiTiAd)

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).

Study Overview

• Status: Terminated
• Conditions: Bariatric Surgery Candidate; Digestive Organs--Cancer; Parietal Region Trauma
• Intervention / Treatment: Procedure: adipose surgery

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 Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France
    • CHU Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All patients; a sample of adipose tissue will be collected during the scheduled surgery	Procedure: adipose 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mitochondrial respiration values depending on patients BMI by oxygraphy	Identification of mitochondrial respiration discrimination factors	day 1
comparing mitochondrial respiration values depending on tissue location by oxygraphy	Identification of mitochondrial respiration discrimination factors	day 1
comparing mitochondrial respiration values depending on anthropometric data by oxygraphy	Identification of mitochondrial respiration discrimination factors	day 1

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Ruddy RICHARD, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2021
• Primary Completion (Actual): April 12, 2023
• Study Completion (Actual): April 12, 2023

Study Registration Dates

• First Submitted: May 17, 2022
• First Submitted That Met QC Criteria: June 9, 2022
• First Posted (Actual): June 14, 2022

Study Record Updates

• Last Update Posted (Actual): October 2, 2023
• Last Update Submitted That Met QC Criteria: September 29, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Body Mass Index; Mitochondria; Adipose Tissue; Digestive surgery; Oxygraphy
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Craniocerebral Trauma
• Other Study ID Numbers: RBHP 2020 RICHARD; 2020-A03309-30 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No