ACTRN12618000862246招募中未知
A randomised, double-blind, placebo-controlled trial to determine whether diet supplementation with low-calorie sweeteners alters the rate of intestinal glucose absorption in patients with type 2 diabetes
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 48
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
- •Volunteers with Type 2 Diabetes Mellitus (American Diabetes Association criteria) managed by diet alone or metformin. In patients treated with metformin, this drug will be withheld for 48 h prior to each study visit, since it has the capacity to stimulate GLP-1 secretion
排除标准
- •i) Significant illness, other than type 2 diabetes, including impairment to cardiovascular or respiratory function that limits a participant’s activity and represents a risk to undertaking endoscopy safely.
- •ii) History of gastrointestinal disease, including significant upper gastrointestinal symptoms (assessed by a validated gastrointestinal symptom questionnaire), pancreatitis, or previous gastrointestinal surgery (other than uncomplicated appendectomy or cholecystectomy)
- •iii) Diffuse mucosal disease involving the upper gastrointestinal tract, including Crohn’s disease, coeliac disease, or ischaemic changes, evident either macroscopically or on histopathological examination of mucosal biopsies.
- •iv) 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 (below 20ng/mL for women and 30ng/mL for men)
- •v) Significant history of migraine
- •vi) 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))
- •vii) Participants medicated with anti-diabetics other than metformin
- •viii) Participants unable to self-monitor blood glucose levels
- •ix) Volunteers with body mass index less than 20 kg/m2
- •x) Donation of blood within the previous 3 months
- •xi) Participation in any other research studies within the previous 3 months
- •xii) Participants medicated with opiates, anticholinergics, levodopa, clonidine, nitrates, phosphodiesterase type 5 inhibitors, sumatriptan, metoclopramide, domperidone, cisapride, tegaserod, or erythromycin
- •xiii) Participants with known coagulopathy, or treated with any antiplatelet or anticoagulant medication
- •xiv) Presence of mucosal abnormalities at endoscopy
- •xv) Evidence of drug abuse, consumption of more than 20 g alcohol or 10 cigarettes per day
- •xvi) Female patients not using appropriate contraceptive method (ie oral contraceptive pill, diaphragm, DepoProvera hormonal contraceptive injection, intrauterine device (IUD), Norplant method)
- •xvii) Vegetarian, lactation, or pregnancy (verified by urine testing in women of reproductive age; in these participants, the study will be completed during the follicular phase of the menstrual cycle)
研究者
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