A Basic Study Using Human Abdominal Adipose Tissue Biopsies to Characterize the Role of Endocannabinoids in Adipocyte Differentiation
ECTADIF
1 other identifier
interventional
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2026
CompletedFirst Posted
Study publicly available on registry
May 5, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
Study Completion
Last participant's last visit for all outcomes
June 1, 2028
May 5, 2026
May 1, 2026
2 years
April 24, 2026
May 4, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Monitoring the differentiation of stem cells from the stromal-vascular fraction into adipocytes
* 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
Study Arms (3)
Control group
OTHERNon-diabetic obese individuals
OTHERObese individuals with diabetes
OTHERInterventions
Collection of small-volume adipose tissue samples (a few cubic centimeters) during a previously scheduled abdominal surgery.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- +28 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chu Dijon Bourgogne
Dijon, France
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2026
First Posted
May 5, 2026
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
June 1, 2028
Last Updated
May 5, 2026
Record last verified: 2026-05