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临床试验/NCT03157778
NCT03157778已完成不适用

Relation Between Pregnenolone Endocannabinoids in Normal-weight and Obese Men

University Hospital, Bordeaux1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2017年5月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
25
试验地点
1
主要终点
Comparison of pregnenolon plasmatic concentration in both groups.

研究概览

简要总结

Measured plasmatic concentration of pregnenolone and endocannabinoid in fasting conditions and over a meal in obese and normal-weight men subjects, to research a dysfunction in the negative feed-back between pregnenolone and CB1 ligand in obese subjects. This dysfunction could participate to the hyperactivity of endocannabinoid system saw in obesity.

详细描述

Endocannabinoid system is an orexigenic key system, controlling the energy balance. It is composed of receptors (ex: CB1), of endogenous ligands, the endocannabinoids (ex: anandamide and 2- arachidonoylglycerol) and of enzymes implied in the synthesis and the degradation of the endocannabinoids. Researches resulting from our group highlighted anomalies of the plasmatic concentrations of endocannabinoid, in obese subject compared to normal-weight subject. Those being higher in obese subject with a flatness of post prandial reduction of AEA, so maintenance of elevated levels which can facilitate the food catch and create a metabolic vicious circle. In addition, prestigious research resulting from our collaborators highlighted in the animal that exposure to tetrahydrocannabinol (THC, ligand exogenic of CB1) induced the synthesis of pregnenolone (neurosteroid) which, by an autocrine effect on the CB1, inhibited the effects of the THC. In particular one of the principal behavioural effects: the food intake.

We want to measure pregnenolone and endocannabinoid concentrations in men blood samples, to observe if this association exists in fasting conditions and over a meal in normal-weight and obese subjects. Obese subjects will be recruited during an hospitalization, while normal subject will be recruited by a poster at Bordeaux university and Haut-Leveque hospital. They will be included at Haut-Leveque hospital during morning at hospital.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •Obese subjects:
  • •aged between 18 and 65 years,
  • •BMI>30kg/m
  • •Normal-weight subjects:
  • •aged between 18 and 65 years,
  • •BMI<25kg/m2.

排除标准

  • •For all subjects:
  • •cannabis detected by urinary tetrahydrocannabinol presence,
  • •treatment which can interfere with endocannabinoid system (antidepressant, antipsychotics, anxiolytics).

研究组 & 干预措施

Obese men

Experimental

Measured plasmatic concentration of pregnenolone and endocannabinoid in fasting conditions and over a meal in obese men.

干预措施: Obese men (Other)

Normal-weight men

Active Comparator

Measured plasmatic concentration of pregnenolone and endocannabinoid in fasting conditions and over a meal in normal-weight men.

干预措施: Normal-weight men (Other)

结局指标

主要结局

Comparison of pregnenolon plasmatic concentration in both groups.

时间窗: Change from 1 hour before lunch to 1 hour after lunch at inclusion day

Pregnenolon plasmatic concentration will be measured at several points.

次要结局

  • Comparison of neurosteroid plasma concentrations and endocannabinoid plasma concentrations(Change from 1 hour before lunch to 1 hour after lunch at inclusion day)
  • Comparison of endocannabinoid plasma concentration and pregnenolone plasma concentration(Change from 1 hour before lunch to 1 hour after lunch at inclusion day)

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (1)

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