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临床试验/ACTRN12613000843752
ACTRN12613000843752尚未招募4 期

In patients with type 2 diabetes as opposed to healthy volunteers, what will the GLP-1 release and expression of glucose sensing molecules be in functionally identified colonic cells, activated by glucose or glibenclamide

Dr. Nam Q Nguyen0 个研究点目标入组 40 人开始时间: 2013年7月31日最近更新:
适应症

试验速览

阶段
4 期
状态
尚未招募
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

入排标准

年龄范围
18 Years 至 75 Years(—)
性别
All

入选标准

  • Patients with type 2 diabetes (World Health Organisation (WHO) criteria) managed by diet alone or metformin, with a HbA1c =/< 7.5%.
  • Healthy volunteers, matched as closely as possible to the diabetic subjects for age, sex, and body mass index.

排除标准

  • Significant illness other than diabetes, including impairment to cardiovascular or respiratory function that limits a subject’s activity and therefore would represent a risk to undertaking endoscopy safely (American Society of Anesthesiologists Grade 3 or more)
  • History of gastrointestinal disease, including significant upper or lower gastrointestinal symptoms (as assessed by a validated upper gastrointestinal symptom questionnaire, pancreatitis, or previous gastrointestinal surgery (other than uncomplicated appendicectomy or cholecystectomy)
  • Haemoglobin below the lower limit of the normal range (ie. <135g/L for men and 115g/L for women), and ferritin below the lower limit of normal (ie. <10mcg/L)
  • Impaired renal or liver function (as assessed by calculated creatinine clearance < 90 mL/min or abnormal liver function tests (> 2 times upper limit of normal))
  • History of severe respiratory, cardiovascular, hepatic and/or renal disease, chronic alcohol abuse or epilepsy (excluded by history)
  • Subjects requiring medication that may influence gastrointestinal function
  • Any patient with coagulopathy.
  • Allergy to glibencamide and/or sulphonamide derivatives
  • Patients with Thrombocytopenia
  • Patients requiring treatment with anticoagulants, anti-platelet agents and NSAIDS
  • Presence of mucosal abnormalities at sigmoidoscopy such as inflammatory bowel disease and colorectal cancer.
  • Body mass index greater than 32 kg/m2
  • Evidence of drug abuse, consumption of more than 20 g alcohol or 10 cigarettes per day
  • Female patients not using appropriate contraceptive method (ie oral contraceptive pill, diaphragm, Depo-Provera hormonal contraceptive injection, intrauterine device (IUD), Norplant method)
  • Vegetarian, lactation, or pregnancy (verified by urine testing in women of reproductive age; in these subjects, the study will be completed during the follicular phase of the menstrual cycle)
  • Donation of blood within the previous 3 months
  • Participation in any other research studies within the previous 3 months

研究者

发起方
Dr. Nam Q Nguyen

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