跳至主要内容
临床试验/NCT04940962
NCT04940962招募中不适用

Translational Study Using Human Abdominal Adipose Tissue Biopsies to Investigate the Role of Cannabinoid Receptor 1 (CB1) in Controlling Endocannabinoid and Adipokine Secretion

Centre Hospitalier Universitaire Dijon1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2021年9月29日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
45
试验地点
1
主要终点
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.

研究概览

简要总结

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:

  1. clarify whether obesity, associated or not with diabetes, leads to an overproduction of ECs (specifying which ones) by visceral or subcutaneous adipose tissue
  2. 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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 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

排除标准

  • Controls:
  • Person not covered by national health insurance.
  • BMI > 30
  • 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
  • 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

结局指标

主要结局

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.

时间窗: 12 hours

The assay will be performed using a technique of liquide chromatography coupled to a mass spectrometer.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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