A Study Using Human Abdominal Adipose Tissue Biopsies to Characterize the Role of Endocannabinoids in Adipocyte Differentiation (ECTADIF)

May 5, 2026 updated by: Centre Hospitalier Universitaire Dijon

A Basic Study Using Human Abdominal Adipose Tissue Biopsies to Characterize the Role of Endocannabinoids in Adipocyte Differentiation

Abdominal obesity and type 2 diabetes are associated with hyperactivation of the endocannabinoid system. Several animal and human studies indicate that circulating endocannabinoid levels correlate with body fat mass. Thus, adipose tissue, which possesses the enzymatic machinery of the endocannabinoid system, may be the primary producer of plasma endocannabinoids.

Today, it is well established that stimulation of the endocannabinoid system, through the activation of cannabinoid receptor 1 (CB1R) located in the brain, leads to increased food intake and weight gain. Furthermore, peripheral CB1R present in adipose tissue are also directly involved in energy storage processes. Indeed, activation of the endocannabinoid system in adipose tissue is associated with stimulation of pathways leading to the uptake of carbohydrates and fatty acids, as well as their storage in the form of triglycerides.

Adipose tissue consists primarily of mature adipocytes, and activation of the endocannabinoid system appears to play a key role in increasing fat mass by promoting the hypertrophy of these adipocytes through the stimulation of lipogenesis. However, the vascular stromal fraction also contains stem cells capable of generating new adipocytes, and an autocrine action of endocannabinoids on progenitor cells could also contribute to its expansion by promoting hyperplasia.

That is why, in this project, the investigators aim to study the impact of endocannabinoids on the differentiation of stem cells from the stromal-vascular fraction into adipocytes. In particular, the investigators will seek to compare the impact of endocannabinoids on the differentiation capacity of stem cells derived from adipose tissue collected from patients with obesity, with or without diabetes, compared to controls.

These data, combined with those obtained in parallel in mice, could help determine whether adipose tissue (visceral and/or subcutaneous) is a priority target for the development of CB1R-blocking molecules (such as rimonabant) with exclusively peripheral action (which do not cross the blood-brain barrier to avoid psychiatric side effects) for the treatment of metabolic obesity and type 2 diabetes.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Control group :

    • Men or postmenopausal women aged 18 to 80
    • Individuals who have provided their free and informed written consent
    • Individuals scheduled to undergo abdominal surgery

  • Non-diabetic obese individuals :

    • Men or postmenopausal women aged 18 to 80
    • BMI > 30 - Individuals who have provided written, free, and informed consent
    • Scheduled to undergo abdominal surgery

  • Obese individuals with diabetes :

    • Men or postmenopausal women aged 18 to 80 with type 2 diabetes not treated with insulin or a GLP-1 agonist
    • BMI > 30
    • Individuals who have provided written, free, and informed consent and are scheduled to undergo abdominal surgery

Exclusion Criteria :

  • Control group :

    • Individuals not enrolled in or eligible for a social security program
    • Individuals subject to legal guardianship (curatorship, guardianship)
    • Individuals subject to judicial protective measures
    • Pregnant women, women in labor, or breastfeeding women
    • Adults who are legally incapacitated or unable to give consent
    • Minors
    • BMI > 30
    • Diabetes
    • Chronic inflammatory disease
    • Cancer undergoing chemotherapy or having undergone chemotherapy within the past year
    • Gastrointestinal cancer with recent weight loss and/or malnutrition
    • Known metastatic cancers
    • Cancers undergoing long-term hormonal therapy
    • Any positive result for screening for human immunodeficiency virus (HIV) infection, hepatitis B surface antigen testing, or testing for antibodies against the hepatitis C virus (HCV) with a positive HCV RNA test.

  • Non-diabetic obese individuals :

    • Individuals not enrolled in or eligible for a social security program
    • Individuals subject to legal guardianship (curatorship, guardianship)
    • Individuals subject to judicial protective measures
    • Pregnant women, women in labor, or breastfeeding women
    • Adults who are legally incapacitated or unable to give consent
    • Minors
    • Diabetes
    • Chronic inflammatory disease
    • Cancer undergoing chemotherapy or having undergone chemotherapy within the past year
    • Gastrointestinal cancer with recent weight loss and/or malnutrition
    • Known metastatic cancers
    • Cancers undergoing long-term hormonal therapy,
    • Any positive result for screening for human immunodeficiency virus (HIV) infection, hepatitis B surface antigen, or antibodies to hepatitis C virus (HCV) with a positive HCV RNA test.

  • Obese individuals with diabetes

    • Individuals not enrolled in or not eligible for a social security program
    • Individuals subject to legal guardianship (curatorship, guardianship)
    • Individuals subject to judicial protective measures
    • Pregnant women, women in labor, or breastfeeding women
    • Adults who are legally incapacitated or unable to give consent
    • Minors
    • Diabetes
    • Chronic inflammatory disease
    • Cancer undergoing chemotherapy or having undergone chemotherapy within the past year
    • Gastrointestinal cancer with recent weight loss and/or malnutrition
    • Known metastatic cancers
    • Cancers undergoing long-term hormonal therapy,
    • Any positive result for screening for human immunodeficiency virus (HIV) infection, hepatitis B surface antigen, or antibodies against hepatitis C virus (HCV) with a positive HCV RNA test.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control group
Diagnostic test: Collection of adipose tissue samples
Collection of small-volume adipose tissue samples (a few cubic centimeters) during a previously scheduled abdominal surgery.
Other: Non-diabetic obese individuals
Diagnostic test: Collection of adipose tissue samples
Collection of small-volume adipose tissue samples (a few cubic centimeters) during a previously scheduled abdominal surgery.
Other: Obese individuals with diabetes
Diagnostic test: Collection of adipose tissue samples
Collection of small-volume adipose tissue samples (a few cubic centimeters) during a previously scheduled abdominal surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Monitoring the differentiation of stem cells from the stromal-vascular fraction into adipocytes
Time Frame: At baseline, biopsies of visceral and subcutaneous adipose tissue will be performed in the operating room during patients' visceral surgery. The samples will be promptly transferred to the INSERM laboratory for stem cell culture to assess adipocyte diffe
  • Stem cell population in the stromal-vascular fraction prior to culture
  • Monitoring of stem cell differentiation into adipocytes in the presence of a CB1 receptor agonist, antagonist, or solvent (Oil Red O staining, mRNA markers, flow cytometry)
  • Kinetics of endocannabinoid release by cells during differentiation, assessed by RT-PCR of mRNAs. Quantification will be performed by liquid chromatography coupled with mass spectrometry (LC-MS).
At baseline, biopsies of visceral and subcutaneous adipose tissue will be performed in the operating room during patients' visceral surgery. The samples will be promptly transferred to the INSERM laboratory for stem cell culture to assess adipocyte diffe

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

April 24, 2026

First Submitted That Met QC Criteria

May 4, 2026

First Posted (Actual)

May 5, 2026

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • VERGES 2025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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