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临床试验/NCT04844684
NCT04844684招募中不适用

Link Between the Metabolism of Cortisol and Bile Acids in Obese Patients Before and After Bariatric Surgery

University Hospital, Lille1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年3月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
Correlation between the variations of urinary cortisol metabolites and plasmatic total BA level before and after RYGB

研究概览

简要总结

Bariatric surgery is currently the most efficient treatment for obesity. The sustained weight loss and metabolic improvement seen following Roux-en-Y gastric bypass (RYGB), is explained partly by modifications in hormones including bile acids (BA). After RYGB, an increased total BA pool and a reduction in hepatic cortisol exposure is observed. Hydroxysteroid 11-β dehydrogenase 1 (HSD11B1), steroid 5α-reductases (SRD5A), and steroid 5β-reductases, AKR1D1 (also a BA metabolizing enzyme), are three enzymes involved in the metabolism of cortisol in the liver and are known to participate in metabolic syndrome. Their activity has been shown to be decreased after RYGB. Interestingly, the mechanisms explaining the modification of hepatic cortisol exposure and the activity of theses enzymes after RYGB are unknown. In view of the few data suggesting a link between cortisol metabolism and bile acids, this work aim to study and characterize this link in a context of RYBP

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Non-menopausal women
  • BMI between 35 and 50 kg/m² included
  • Social insured
  • Ability to give consent

排除标准

  • moderate and severe kidney insufficiency
  • hepatic insufficiency
  • known gallbladder lithiasis
  • history of cholecystectomy or cholecystectomy planned during the gastric bypass
  • history of bariatric surgery except gastric band and gastric balloon
  • history of type 1
  • treatment interfering with the cortisol metabolism: taking oral or inhaled glucocorticoids within the last 6 months
  • treatment by BA as ursodeoxycholic acid, bile acids sequester, statin, fibrate stopped less than 4 weeks ago

结局指标

主要结局

Correlation between the variations of urinary cortisol metabolites and plasmatic total BA level before and after RYGB

时间窗: At 1 year

次要结局

  • Urinary cortisol metabolite profile modification(At 1 month after RYGP, at 1 year after RYGP)
  • Urinary and plasmatic BA profile modification(At 1 month after RYGP, at 1 year after RYGP)
  • Correlation between the variations of cortisol metabolites and the variations of metabolic parameters 1 year after gastric bypass(at 1 year)

研究者

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

研究点 (1)

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