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

5 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Tipo di studio

Interventistico

Iscrizione (Stimato)

30

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: Gruppo di controllo
Collection of small-volume adipose tissue samples (a few cubic centimeters) during a previously scheduled abdominal surgery.
Altro: Non-diabetic obese individuals
Collection of small-volume adipose tissue samples (a few cubic centimeters) during a previously scheduled abdominal surgery.
Altro: Obese individuals with diabetes
Collection of small-volume adipose tissue samples (a few cubic centimeters) during a previously scheduled abdominal surgery.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Monitoring the differentiation of stem cells from the stromal-vascular fraction into adipocytes
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

1 giugno 2028

Completamento dello studio (Stimato)

1 giugno 2028

Date di iscrizione allo studio

Primo inviato

24 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

4 maggio 2026

Primo Inserito (Effettivo)

5 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • VERGES 2025

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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