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

Bariatric Surgery Candidate Clinical Trial

— OxMiTiAd  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05417581
• Other study ID #: RBHP 2020 RICHARD
• Secondary ID: 2020-A03309-30
• Status: Terminated
• Phase: N/A
• Start date: April 14, 2021
• Est. completion date: April 12, 2023

Study information

• Verified date: September 2023
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 67
• Est. completion date: April 12, 2023
• Est. primary completion date: April 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Craniocerebral Trauma

Intervention

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)

Locations

Country	Name	City	State
France	CHU clermont-ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	mitochondrial respiration values depending on patients BMI by oxygraphy	Identification of mitochondrial respiration discrimination factors	day 1
Secondary	comparing mitochondrial respiration values depending on tissue location by oxygraphy	Identification of mitochondrial respiration discrimination factors	day 1
Secondary	comparing mitochondrial respiration values depending on anthropometric data by oxygraphy	Identification of mitochondrial respiration discrimination factors	day 1