- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07567287
A Study Using Human Abdominal Adipose Tissue Biopsies to Characterize the Role of Endocannabinoids in Adipocyte Differentiation (ECTADIF)
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
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Bruno VERGES
- Numero di telefono: +33 03.80.29.38.54
- Email: bruno.verges@chu-dijon.fr
Luoghi di studio
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Dijon, Francia
- CHU Dijon Bourgogne
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Contatto:
- Bruno VERGES
- Numero di telefono: +33 03.80.29.38.54
- Email: bruno.verges@chu-dijon.fr
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Criteri di partecipazione
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
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 |
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Altro: Gruppo di controllo
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Collection of small-volume adipose tissue samples (a few cubic centimeters) during a previously scheduled abdominal surgery.
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Altro: Non-diabetic obese individuals
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Collection of small-volume adipose tissue samples (a few cubic centimeters) during a previously scheduled abdominal surgery.
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Altro: Obese individuals with diabetes
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Collection of small-volume adipose tissue samples (a few cubic centimeters) during a previously scheduled abdominal surgery.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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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
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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
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Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
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
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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 .