ACTRN12618001747213尚未招募未知
Effects of the non-nutritive bitter taste flavouring, denatonium benzoate (DB), and the low-nutritive bitter taste amino acid, leucine, on gastrointestinal hormone secretion and energy intake in health and type 2 diabetes – regional differences in small intestinal exposure.
niversity of Adelaide0 个研究点目标入组 40 人开始时间: 2018年10月24日最近更新:
适应症
试验速览
- 阶段
- 未知
- 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
- 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
- •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 20-35 kg/m2, both males and females aged 18-75 years.
- •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 more than 20mg/mL for women)
排除标准
- •Use of any medication that may influence gastrointestinal motor function, body weight or appetite (e.g. antihypertensive drugs, 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 < 90 mL/min or abnormal liver function tests (> 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
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