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Obesity and Lipids: a Matter of Taste? (HumanFATaste)

Obesity and Lipids: a Matter of Taste? Impact of Bariatric Surgery on Taste Receptors

The purpose of the protocol is to determine the impact of bariatric surgery on taste receptors and taste perceptions and to precise the factors implicated in taste alterations in 50 obese patients before and 6 months after bariatric surgery (25 Roux Y gastric bypass and 25 sleeve gastrectomy).

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

Over-consumption high sugar and high fat foods was identified as a main risk factor for obesity. The recent identification of lipid-receptor (CD36, GPR120) in human taste buds suggests that lipids could be perceived not only by their texture and their olfactory characteristics, but also by way of taste. Obese subjects tend to consume more high fat foods than lean subjects. Conversely, bariatric surgery induces behavioral changes limiting the consumption of foods high in sugar and fat. The mechanisms underlying these behavioral changes are not understood. Does obesity is accompanied by a distortion of taste detection of dietary lipids? What are the mechanisms involved? Are they reversible? What could be the effect on food choices and health? This protocol is part of a broader research program that aims to answer these questions by studying the feeding behavior in obese subjects and animals before and after a bariatric surgery.

The purpose of the protocol is to determine the impact of bariatric surgery on the expression of taste receptors and taste perceptions and in particular the threshold of perception of fat (and sweet as taste as reference) and to study the association between the changes of taste perceptions and food preferences, amount of weight loss, surgical technique (with or without intestinal bypass), hormonal, metabolic and inflammatory changes, and modification of the oral microbiota. The study will included 50 patients who underwent bariatric surgery, either Roux Y gastric bypass (25 patients) or sleeve gastrectomy (25 patients) that will be explored in the two months before and six months after surgery. These explorations will included a clinical examination with collection of anthropometric data, a body fat determination by impedance, a detailed dietary survey, blood samples for assessment of hormonal parameters (GLP1 , PYY, ghrelin, insulin, leptin) and inflammatory parameters (LPS, TNFalpha, IL-1, IL-6, ...), a tong micro-biopsy to collect taste buds and a sample of oral microbiota and lipids and sugars thresholds determination (linoleic acid or sucrose).

Tipo de estudio

Intervencionista

Inscripción (Actual)

20

Fase

  • No aplica

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 55 años (Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Descripción

Inclusion Criteria:

  • Affiliation to a health insurance
  • Patients candidates for bariatric surgery based on criteria established by international experts (BMI> 40 or> 35 kg / m² with severe comorbidities, after failure of multidisciplinary care for a period of at least 1 year)
  • Written consent after oral and written informations

Exclusion Criteria:

  • Topic guardianship, curatorship or safeguard justice.
  • Taking a treatment known to alter the perception of taste
  • Oral Decay can affect the perception of taste
  • Treatment that may interfere with intestinal peptides or lipids receptors (especially DDP4 inhibitors, anti-inflammatory medications, intestinal lipase inhibitors: Xenical)
  • Tobacco use, alcohol or drugs abuse
  • Known coagulopathy, abnormal hemostasis tests or abnormal platelets count, treatment interfering with coagulation or platelet aggregation
  • Contraindication to bariatric surgery
  • Malignant pathology, severe liver disease or severe inflammatory disease, malabsorption.
  • Pregnancy
  • Positive serology for VIH, VBH and CVH

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Ciencia básica
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Roux Y gastric bypass
candidates for bariatric surgery by Roux Y gastric bypass with taste assessment and epithelium gustatory smear and biopsy
assessment of taste perceptions and expression of taste receptors before and after bariatric surgery and epithelium gustatory smear and biopsy
Experimental: Sleeve gastrectomy
candidates for bariatric surgery by sleeve gastrectomy with taste assessment and epithelium gustatory smear and biopsy
assessment of taste perceptions and expression of taste receptors before and after bariatric surgery and epithelium gustatory smear and biopsy

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Expression of lipid receptors
Periodo de tiempo: before and 6 months after bariatric surgery
To compare the expression of lipid receptors expressed in the taste buds before and after a significant weight loss induced by bariatric surgery
before and 6 months after bariatric surgery

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Lipids thresholds
Periodo de tiempo: before and 6 months after bariatric surgery
To determine the relationship between taste receptor expression and changes in lipid and sugar perception thresholds before and after surgery
before and 6 months after bariatric surgery

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Factors associated with taste perception
Periodo de tiempo: before and 6 months after bariatric surgery
To identify the factors associated with the expression and functionality of taste receptors before and after bariatric surgery: body fat, metabolic, endocrine and inflammatory parameters and peripapillary microbiota.
before and 6 months after bariatric surgery
Influence of surgical technique on taste perception
Periodo de tiempo: before and 6 months after bariatric surgery
To compare the effect of RYGBP which bypass the proximal gut with changes in intestinal endocrine secretions and lipid absorption, to that of SG that is a pure restrictive technique without intestinal bypass.
before and 6 months after bariatric surgery

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Séverine Ledoux, APHP-INSERM

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

11 de enero de 2016

Finalización primaria (Actual)

1 de enero de 2019

Finalización del estudio (Actual)

1 de enero de 2019

Fechas de registro del estudio

Enviado por primera vez

8 de julio de 2015

Primero enviado que cumplió con los criterios de control de calidad

10 de julio de 2015

Publicado por primera vez (Estimar)

14 de julio de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

26 de agosto de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

25 de agosto de 2021

Última verificación

1 de agosto de 2021

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • C14-77
  • 2015-A00906-43 (Identificador de registro: ID-RCB)

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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