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

9. september 2026 oppdatert av: 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.

Studieoversikt

Studietype

Intervensjonell

Registrering (Antatt)

30

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: Kontrollgruppe
Collection of small-volume adipose tissue samples (a few cubic centimeters) during a previously scheduled abdominal surgery.
Annen: Non-diabetic obese individuals
Collection of small-volume adipose tissue samples (a few cubic centimeters) during a previously scheduled abdominal surgery.
Annen: Obese individuals with diabetes
Collection of small-volume adipose tissue samples (a few cubic centimeters) during a previously scheduled abdominal surgery.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Monitoring the differentiation of stem cells from the stromal-vascular fraction into adipocytes
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

3. september 2026

Primær fullføring (Antatt)

1. september 2028

Studiet fullført (Antatt)

1. september 2028

Datoer for studieregistrering

Først innsendt

24. april 2026

Først innsendt som oppfylte QC-kriteriene

4. mai 2026

Først lagt ut (Faktiske)

5. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • VERGES 2025

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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