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

9 de setembro de 2026 atualizado por: 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.

Visão geral do estudo

Tipo de estudo

Intervencional

Inscrição (Estimado)

30

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Descrição

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.

Plano de estudo

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Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Ciência básica
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Outro: Grupo de controle
Collection of small-volume adipose tissue samples (a few cubic centimeters) during a previously scheduled abdominal surgery.
Outro: Non-diabetic obese individuals
Collection of small-volume adipose tissue samples (a few cubic centimeters) during a previously scheduled abdominal surgery.
Outro: Obese individuals with diabetes
Collection of small-volume adipose tissue samples (a few cubic centimeters) during a previously scheduled abdominal surgery.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Monitoring the differentiation of stem cells from the stromal-vascular fraction into adipocytes
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

3 de setembro de 2026

Conclusão Primária (Estimado)

1 de setembro de 2028

Conclusão do estudo (Estimado)

1 de setembro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

24 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

4 de maio de 2026

Primeira postagem (Real)

5 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

11 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

9 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • VERGES 2025

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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