ACTRN12622001506785招募中3 期
Do short acting glucagon-like receptor agonists (GLP-1 RAs) attenuate the 'gastric' counter-regulatory response to hypoglycaemia in type 2 diabetes?
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 12
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
- Prevention
入排标准
- 年龄范围
- 40 Years 至 70 Years（—）
- 性别
- All
入选标准
- •Men and women with type 2 diabetes either diet controlled or metformin alone
- •Aged 40 - 70 years
- •Body Mass Index 20-40 kg/m²
- •HbA1c less than or equal to 8.5 %
排除标准
- •History of type 1 diabetes or on medications other than metformin
- •HbA1c >8.5 %
- •History of gastrointestinal disease, including known gastroparesis, peptic ulcer disease, significant upper or lower gastrointestinal symptoms, or previous gastrointestinal surgery (other than uncomplicated appendicectomy or cholecystectomy) or a history of migraine or panic attacks.
- •Other significant illness, including epilepsy, cardiovascular or respiratory disease.
- •Impaired renal function (as assessed by calculated creatinine clearance < 50 mL/min using the Cockcroft-Gault equation) or if iron stores or liver function tests are outside the following normal ranges:
- •-Alanine aminotransferase (ALT)< 110 U/L
- •-Alkaline phosphatase (ALP)30 - 110 U/L
- •-Aspartate transaminase (AST)< 90 U/L
- •-Total bilirubin2 - 24 µmol/L
- •-Haemoglobin130 – 180 g/L (Males)
- •-Haemoglobin115 – 155 g/L (Females)
- •-Ferritin> 30 µg/L (Males)
- •-Ferritin> 15 µg/L
- •Requirement for medication known to influence gastrointestinal function, (e.g. prokinetic drugs [metoclopramide, domperidone, erythromycin], antiemetics [ondansetron], antidiarrhoeals [loperamide], H2 receptor antagonists [ranitidine], drugs with substantial anticholinergic effects [amitriptyline, doxepin, dothiepin, mirtazapine, haloperidol, chlorpromazine, risperidone, oxybutynin], opioids [morphine, oxycodone, codeine], orlistat.
- •Evidence of drug or alcohol abuse, or consumption of more than 20 g alcohol or 10 cigarettes on a daily basis.
- •Vegetarian
- •Donation of blood within the previous 3 months
- •Participation in any other research studies within the previous 3 months
- •Previous exposure to radiation for research purposes in the preceding 12 months
- •Inability to give informed consent
- •Positive pregnancy status or lactating (breast-feeding) female
- •Contra-indication to use of exenatide
- •A known history of intolerance or unwilling to self-inject exenatide
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