- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04940962
Estudio traslacional que utiliza biopsias de tejido adiposo abdominal humano para investigar el papel del receptor de cannabinoides 1 (CB1) en el control de la secreción de endocannabinoides y adipoquinas (ENDOCATA)
Abdominal obesity and type 2 diabetes are associated with the hyperactivation of the endocannabinoid system. Several animal and human studies indicate that circulating endocannabinoid (EC) levels are correlated with body fat. Thus, adipose tissue, which possesses the enzymatic machinery for the synthesis of ECs, could be the main producer of plasma ECs.
Today, it is clearly established that stimulation of the endocannabinoid system, via activation of cannabinoid receptor 1 (CB1s) located in the brain, leads to increased food intake and weight gain. Moreover, peripheral CB1s present in organs such as the liver, muscles and adipose tissue are involved in the establishment of metabolic deregulations linked to obesity (steatosis, insulin resistance, dyslipidemia).
Thus, ECs produced by adipose tissue could play a key role in the regulation of carbohydrate-lipid homeostasis through their autocrine or paracrine actions by activating central and peripheral CB1s. Therefore, the objective of this study is to:
- clarify whether obesity, associated or not with diabetes, leads to an overproduction of ECs (specifying which ones) by visceral or subcutaneous adipose tissue
- to determine whether blocking CB1s with new peripherally acting antagonists can lead to a reduction in the production of ECs by adipose tissue.
This study will also provide an opportunity to evaluate the production of adipokines and cytokines involved in the control of energy homeostasis under the different experimental conditions.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Dijon, Francia
- Chu Dijon Bourgogne
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Controls:
- men or post-menopausal women aged between 18 and 80
- gave oral consent
- to undergo visceral surgery
Non-diabetic obese subjects:
- men or post-menopausal women aged between 18 and 80
- BMI > 30
- gave oral consent
- to undergo visceral surgery
Obese diabetic subjects:
- men or post-menopausal women aged between 18 and 80
- type 2 diabetic not treated with Insulin or GLP-1 agonist
- BMI > 30
- gave oral consent
- to undergo visceral surgery
Exclusion Criteria:
- Controls:
- Person not covered by national health insurance.
- BMI > 30
- diabetes
- chronic inflammatory disease
- cancer undergoing chemotherapy or chemotherapy less than a year old
- digestive cancer with recent weight loss (≥10%) and/or malnutrition
- known metastatic cancer
- cancer undergoing long-term hormonal treatment
- protected adult
Non-diabetic obese subjects:
- Person not covered by national health insurance
- diabetes
- chronic inflammatory disease
- cancer undergoing chemotherapy or chemotherapy less than a year old
- digestive cancer with recent weight loss (≥10%) and/or malnutrition
- known metastatic cancer
- cancer undergoing long-term hormonal treatment
- protected adult
Obese diabetic subjects:
- Person not covered by national health insurance
- chronic inflammatory disease
- cancer undergoing chemotherapy or chemotherapy less than a year old
- digestive cancer with recent weight loss (≥10%) and/or malnutrition
- known metastatic cancer
- cancer undergoing long-term hormonal treatment
- type 1 diabetes
- secondary diabetes
- protected adult
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Obesidad no diabética
|
Removal of less than 1 cm3 of adipose tissue during visceral surgery |
|
Experimental: Obeso diabético
|
Removal of less than 1 cm3 of adipose tissue during visceral surgery |
|
Comparador activo: Testigos
|
Removal of less than 1 cm3 of adipose tissue during visceral surgery |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Kinetics of the appearance of endocannabinoids produced by visceral adipose tissue explants in culture medium estimated by the area under the curve in obese subjects and in controls.
Periodo de tiempo: 12 hours
|
The assay will be performed using a technique of liquide chromatography coupled to a mass spectrometer. |
12 hours
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades del sistema endocrino
- Trastornos Nutricionales
- Enfermedades metabólicas
- Sobrenutrición
- Peso corporal
- Trastornos del metabolismo de la glucosa
- Diabetes mellitus
- Exceso de peso
- Obesidad
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades Nutricionales y Metabólicas
- Signos y síntomas
- Diabetes Mellitus, Tipo 2
- Obesidad Abdominal
Otros números de identificación del estudio
- VERGES 2020
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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