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

NCT ID: NCT04940962

Last Updated: 2025-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-29

Study Completion Date

2027-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diabete Type 2 Abdominal Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Non-diabetic obese

Group Type EXPERIMENTAL

Sampling of adipose tissue

Intervention Type PROCEDURE

Removal of less than 1 cm3 of adipose tissue during visceral surgery

Diabetic obese

Group Type EXPERIMENTAL

Sampling of adipose tissue

Intervention Type PROCEDURE

Removal of less than 1 cm3 of adipose tissue during visceral surgery

Witnesses

Group Type ACTIVE_COMPARATOR

Sampling of adipose tissue

Intervention Type PROCEDURE

Removal of less than 1 cm3 of adipose tissue during visceral surgery

Interventions

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Sampling of adipose tissue

Removal of less than 1 cm3 of adipose tissue during visceral surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu Dijon Bourgogne

Dijon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Pablo ORTEGA DEBALLON

Role: CONTACT

03.80.29.37.47

Facility Contacts

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Isabelle SIMONEAU

Role: primary

0380293332

Other Identifiers

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VERGES 2020

Identifier Type: -

Identifier Source: org_study_id

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