跳至主要内容
临床试验/NCT03008525
NCT03008525招募中不适用

Vitamin D and Its Metabolites Quantification in Adipose Tissues of Obese and Non-obese

Assistance Publique Hopitaux De Marseille2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年3月17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
60
试验地点
2
主要终点
quantification of VD and its metabolites on subcutaneous and visceral adipose tissue biopsies

研究概览

简要总结

Vitamin D (VD) is a pleiotropic hormone, involved in many physiological processes including calcium and phosphorus absorption. The VD metabolism begin to be well-known and involves a hepatic hydroxylation (mediated by enzymes, which belong to the cytochrome P450 family) leading to the production of the 25(OH)D, which corresponds to the circulating form of the VD. After circulation in blood, the 25(OH)D is submitted to a second hydroxylation in the kidney resulting to the generation of 1,25(OH)2D, the active metabolite of VD. Numerous epidemiological studies reported an inverse relationship between obesity and circulation level of 25(OH)D. Several mechanisms could explain the low level of 25(OH)D observed in obese subjects, the more classical evoked being based on sequestration and/or dilution of VD in adipose tissue (AT), the main VD storage site. However, this mechanism has never been demonstrated. In order to confirm this hypothesis, the concentration of VD and its metabolites in adipose tissue need to be quantified.

The objective of this study is to determine the concentration of VD and its metabolites in adipose tissue as well as adipose tissue mass quantification and distribution (visceral or subcutaneous) to highlight putative difference of VD and its metabolites quantities between obese and non-obese patients. A quantification of VD metabolism, inflammation and lipid metabolism gene expression will be realized on biopsies. Correlations between gene expression and quantity of VD in tissue will be carrying out.

研究设计

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

入排标准

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

入选标准

  • Subject with a BMI greater than 35 kg / m2 (group OB) or less than 30 kg / m² (group NO)
  • Subject undergoing bariatric surgery (OB group) or abdominal surgery (group NO)

排除标准

  • Regular intake of dietary supplements or vitamin supplements in the last three months
  • For the subjects of the group NO:
  • Malnourished patient (BMI <18.5 kg / m2, weight loss greater than 5% in 1 month or 10% in 6 months)
  • Subject with an infection or inflammatory syndrome (CRP> 10 mg / L and / or white blood cells> 12000 / mm3)
  • Non-cancerous subject

结局指标

主要结局

quantification of VD and its metabolites on subcutaneous and visceral adipose tissue biopsies

时间窗: 12 months

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 (2)

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