NCT07567287

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

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
24mo left

Started Jun 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 5, 2026

Completed
27 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

May 5, 2026

Status Verified

May 1, 2026

Enrollment Period

2 years

First QC Date

April 24, 2026

Last Update Submit

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

OTHER
Diagnostic Test: Collection of adipose tissue samples

Non-diabetic obese individuals

OTHER
Diagnostic Test: Collection of adipose tissue samples

Obese individuals with diabetes

OTHER
Diagnostic Test: Collection of adipose tissue samples

Interventions

Collection of small-volume adipose tissue samples (a few cubic centimeters) during a previously scheduled abdominal surgery.

Control groupNon-diabetic obese individualsObese individuals with diabetes

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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

Locations