Translational Study Using Human Abdominal Adipose Tissue Biopsies to Investigate the Role of Cannabinoid Receptor 1 (CB1) in Controlling Endocannabinoid and Adipokine Secretion

Abdominal Obesity Clinical Trial

— ENDOCATA  

Official title:

Translational Study Using Human Abdominal Adipose Tissue Biopsies to Investigate the Role of Cannabinoid Receptor 1 (CB1) in Controlling Endocannabinoid and Adipokine Secretion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04940962
• Other study ID #: VERGES 2020
• Status: Recruiting
• Phase: N/A
• Start date: September 29, 2021
• Est. completion date: September 2025

Study information

• Verified date: August 2023
• Source: Centre Hospitalier Universitaire Dijon
• Contact: Pablo ORTEGA DEBALLON
• Phone: 03.80.29.37.47
• Email: pablo.ortega-deballon[@]chu-dijon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Abdominal obesity and type 2 diabetes are associated with the hyperactivation of the endocannabinoid system. Several animal and human studies indicate that circulating endocannabinoid (EC) levels are correlated with body fat. Thus, adipose tissue, which possesses the enzymatic machinery for the synthesis of ECs, could be the main producer of plasma ECs. Today, it is clearly established that stimulation of the endocannabinoid system, via activation of cannabinoid receptor 1 (CB1s) located in the brain, leads to increased food intake and weight gain. Moreover, peripheral CB1s present in organs such as the liver, muscles and adipose tissue are involved in the establishment of metabolic deregulations linked to obesity (steatosis, insulin resistance, dyslipidemia). Thus, ECs produced by adipose tissue could play a key role in the regulation of carbohydrate-lipid homeostasis through their autocrine or paracrine actions by activating central and peripheral CB1s. Therefore, the objective of this study is to: 1. clarify whether obesity, associated or not with diabetes, leads to an overproduction of ECs (specifying which ones) by visceral or subcutaneous adipose tissue 2. to determine whether blocking CB1s with new peripherally acting antagonists can lead to a reduction in the production of ECs by adipose tissue. This study will also provide an opportunity to evaluate the production of adipokines and cytokines involved in the control of energy homeostasis under the different experimental conditions.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Controls:
• men or post-menopausal women aged between 18 and 80
• gave oral consent
• to undergo visceral surgery

Non-diabetic obese subjects:

• men or post-menopausal women aged between 18 and 80
• BMI > 30
• gave oral consent
• to undergo visceral surgery

Obese diabetic subjects:

• men or post-menopausal women aged between 18 and 80
• type 2 diabetic not treated with Insulin or GLP-1 agonist
• BMI > 30
• gave oral consent
• to undergo visceral surgery

Exclusion Criteria:

• Controls:
• Person not covered by national health insurance.
• BMI > 30
• diabetes
• chronic inflammatory disease
• cancer undergoing chemotherapy or chemotherapy less than a year old
• digestive cancer with recent weight loss (=10%) and/or malnutrition
• known metastatic cancer
• cancer undergoing long-term hormonal treatment
• protected adult

Non-diabetic obese subjects:

• Person not covered by national health insurance
• diabetes
• chronic inflammatory disease
• cancer undergoing chemotherapy or chemotherapy less than a year old
• digestive cancer with recent weight loss (=10%) and/or malnutrition
• known metastatic cancer
• cancer undergoing long-term hormonal treatment
• protected adult

Obese diabetic subjects:

• Person not covered by national health insurance
• chronic inflammatory disease
• cancer undergoing chemotherapy or chemotherapy less than a year old
• digestive cancer with recent weight loss (=10%) and/or malnutrition
• known metastatic cancer
• cancer undergoing long-term hormonal treatment
• type 1 diabetes
• secondary diabetes
• protected adult

Related Conditions & MeSH terms

• Abdominal Obesity
• Diabete Type 2
• Diabetes Mellitus, Type 2
• Obesity, Abdominal

Intervention

Procedure:
• Sampling of adipose tissue
Removal of less than 1 cm3 of adipose tissue during visceral surgery

Locations

Country	Name	City	State
France	Chu Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kinetics of the appearance of endocannabinoids produced by visceral adipose tissue explants in culture medium estimated by the area under the curve in obese subjects and in controls.	The assay will be performed using a technique of liquide chromatography coupled to a mass spectrometer.	12 hours