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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04940962
Other study ID # VERGES 2020
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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