跳至主要内容
临床试验/EUCTR2018-000677-77-BE
EUCTR2018-000677-77-BE进行中(未招募)1 期

ovel strategies in weight loss in women with polycystic ovary syndrome: does the gut microbiome play a role?

niversity Hospital Leuven0 个研究点目标入组 60 人开始时间: 2018年3月29日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
60

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
Female

入选标准

  • Women aged between 18 and 40 years, with PCOS presenting anovulation, hyperandrogenism and polycystic ovarian morphology and who are at risk for metabolic syndrome:
  • oBMI = 27 kg/m2 and one of the risk factors of metabolic syndrome according to the International Diabetes Federation (IDF) consensus worldwide definition of the metabolic syndrome 2006
  • oBMI = 30 kg/m2
  • and who have no known inflammatory bowel disease or auto-immune disease
  • and who have access to a -20°C freezer
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 60
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • women will be excluded from participation in case of:
  • -pregnancy
  • -use of oral contraceptive pill
  • -use of immunomodulatory drugs, antidiabetic drugs or anti-inflammatory drugs on a daily basis
  • -inflammatory bowel disease, autoimmune disease
  • -(medical history of) pancreatitis

研究者

发起方
niversity Hospital Leuven

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