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临床试验/ACTRN12619001086156
ACTRN12619001086156招募中未知

Effects of endogenous bile acids on postprandial glucose metabolism in health and type 2 diabetes, and the impact of small intestinal region exposed.

niversity of Adelaide0 个研究点目标入组 40 人开始时间: 2019年8月6日最近更新:
适应症

试验速览

阶段
未知
状态
招募中
发起方
入组人数
40

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 75 Years(—)
性别
All

入选标准

  • (i)Patients with type 2 diabetes (World Health Organisation (WHO) criteria), HbA1c less than or equal to 8.5%, managed by diet or metformin alone, body mass index from 20 to 35 kg/m2, both males and females aged from 18 to 75 years
  • (ii)Healthy volunteers, matched as closely as possible to the diabetic subjects for age, sex, and BMI.
  • Additional inclusion criteria include: haemoglobin above the lower limit of the normal range (ie. more than 135g/L for men and 115g/L for women), and ferritin above the lower limit of normal (ie. more than 30ng/mL for men and 20mg/mL for women)

排除标准

  • Exclusion criteria
  • Use of any medication that may influence gastrointestinal motor function, bile acid metabolism, body weight or appetite (e.g. bile acid sequestrants, domperidone and cisapride, anticholinergic drugs (e.g. atropine), metoclopramide, erythromycin, hyoscine, orlistat, green tea extracts, Astragalus, St. John's Wort etc.)
  • Evidence of drug abuse, consumption of more than 20 g alcohol or 10 cigarettes on a daily basis
  • History of gastrointestinal disease, including significant upper or lower gastrointestinal symptoms, pancreatitis, or previous gastrointestinal surgery (other than uncomplicated appendicectomy or cholecystectomy)
  • Other significant illness, including epilepsy, cardiovascular or respiratory disease
  • Impaired renal or liver function (as assessed by calculated creatinine clearance less than 90 mL/min or abnormal liver function tests (more than 2 times upper limit of normal range))
  • Donation of blood within the previous 3 months
  • Participation in any other research studies within the previous 3 months
  • Inability to give informed consent
  • Female participants who are pregnant or planning for pregnancy, or are lactating
  • Vegetarians

研究者

发起方
niversity of Adelaide

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