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

9 septembre 2026 mis à jour par: 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.

Aperçu de l'étude

Type d'étude

Interventionnel

Inscription (Estimé)

30

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

La 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Science basique
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Autre: Groupe de contrôle
Collection of small-volume adipose tissue samples (a few cubic centimeters) during a previously scheduled abdominal surgery.
Autre: Non-diabetic obese individuals
Collection of small-volume adipose tissue samples (a few cubic centimeters) during a previously scheduled abdominal surgery.
Autre: Obese individuals with diabetes
Collection of small-volume adipose tissue samples (a few cubic centimeters) during a previously scheduled abdominal surgery.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Monitoring the differentiation of stem cells from the stromal-vascular fraction into adipocytes
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

3 septembre 2026

Achèvement primaire (Estimé)

1 septembre 2028

Achèvement de l'étude (Estimé)

1 septembre 2028

Dates d'inscription aux études

Première soumission

24 avril 2026

Première soumission répondant aux critères de contrôle qualité

4 mai 2026

Première publication (Réel)

5 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

11 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

9 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • VERGES 2025

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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