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临床试验/EUCTR2016-001850-16-DK
EUCTR2016-001850-16-DK进行中(未招募)1 期

Studies of interplays between insulin resistance associated with immunosuppression and the gut and saliva microbiota composition of young, healthy men - GEMP

niversity of Copenhagen, The Novo Nordisk Foundation Center For Basic Metabolic Research, Section of Metabolic Genetic0 个研究点开始时间: 2016年5月24日最近更新:
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试验速览

阶段
1 期
状态
进行中(未招募)
发起方

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
Male

入选标准

  • -Age 18-35 years, both inclusive
  • -18.5 kg/m2 < Body Mass Index (BMI) < 27.0 kg/m2
  • -Weight stable, defined by no history of loss or gain of more than 3kg, two months prior to
  • recruitment
  • -Normal glucose metabolism evaluated at the time of screening by Glycosylated Hemoglobin, Type A1c (HbA1c) < 39mmol/mol
  • -Normal kidney functions as evaluated by normal plasma creatinine levels adjusted for age
  • -Normal liver function as evaluated by plasma Alanine Amino Transferase (ALAT) 10-70 IU/L
  • -Normal blood pressure measured with a calibrated automated sphygmomanometer. Systolic pressure < 140mmHg and diastolic pressure < 90mmHg
  • 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

  • -Smoking on daily basis
  • -Oral intake of any form of prescribed medication four months prior to recruitment
  • -Daily use of probiotics four months prior to recruitment
  • -Deliberate changes in diet two months prior to recruitment
  • -Chronic or acute (the latter within the recent two months) illness of any type
  • -Previous gastrointestinal operation, disregarding uncomplicated appendicitis
  • -Previous mental disorders
  • -Unable to give informed consent
  • -Need of medical treatment during the study

研究者

发起方
niversity of Copenhagen, The Novo Nordisk Foundation Center For Basic Metabolic Research, Section of Metabolic Genetic

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