跳至主要内容
临床试验/NL-OMON26916
NL-OMON26916招募中不适用

Role of bacterioPhages In gut Microbiome composition and glucose metabolism in Metabolic Syndrome subjects

Investigator initiated0 个研究点目标入组 24 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
24

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • Caucasian male/female
  • Age: =18 years old
  • BMI: =25 kg/m2
  • At least 3 of the following criteria:
  • oFasting plasma glucose =5.6 mmol/L OR HOMA-IR index =2.5 (HOMA-IR is measured as (fasting insulin (pmol/L) x fasting glucose (mmol/L)) / 135)
  • oWaist-circumference =102 cm
  • oHDL-cholesterol =1.02 mmol/L
  • oBlood pressure =130/85 mmHg
  • oTriglycerides =1.7 mmol/L
  • Subjects should be able to give informed consent

排除标准

  • A history of cardiovascular event (cerebrovascular accident (CVA), myocardial infarction (MI)) or pacemaker implantation
  • Use of any medication including proton pump inhibitors, antibiotics and pro-/prebiotics in the past three months or during the study period
  • (Expected) prolonged compromised immunity (due to recent cytotoxic chemotherapy or human immunodeficiency viruses (HIV) infection with a CD4 count < 240/mm3)
  • Presence of overt type 1 diabetes mellitus (T1DM) or T2D
  • History of chronic diarrhoea (=3 stools/day for >4 weeks), chronic obstipation (<2 defecations/week for >3 months), Irritable Bowel Syndrome (IBS) (according to Rome IV criteria) or Inflammatory Bowel Disease (IBD).
  • Smoking or illicit drug use (MDMA/amphetamine/cocaine/heroin/GHB) in the past three months or use during the study period
  • Use of >5 units of alcohol daily on average in the past three months or use of >2 units of alcohol during the study period
  • History of cholecystectomy

研究者

发起方
Investigator initiated

相似试验