ACTRN12614001117606招募中4 期
Defining the role of endogenous glucagon-like peptide-1 (GLP-1) in the glycaemic, triglyceride and energy expenditure responses to fat in patients with Type 2 Diabetes (T2D) using Galvus (vildagliptin) and the GLP-1 receptor antagonist exendin (9-39)
Dr Tanya Little0 个研究点目标入组 20 人开始时间: 2014年10月22日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
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
- 40 Years 至 75 Years（—）
- 性别
- All
入选标准
- •Patients with type 2 diabetes managed by diet alone or Metformin
- •- glycated haemoglobin (HbA1c) greater than or equal to 6.0% and less than or equal to 7.9%
- •- body mass index of 25-35 kg/m2
- •- aged between 40-75 years
- •- Males and post-menopausal females (to control for the effect of the menstrual cycle on gut hormone secretion)
- •- Haemoglobin above the lower limit of the normal range (i.e. >135g/L for men and 115g/L for women), and ferritin above the lower limit of normal (i.e. >10mcg/L)
排除标准
- •- use of oral hypoglycaemic drugs other than Metformin or insulin
- •- significant gastrointestinal symptoms; disease or surgery
- •- current use of any prescribed or non-prescribed medications, that may affect gastrointestinal function within 48 hours of the study (e.g. domperidone and cisapride, anticholinergic drugs (e.g. atropine), metoclopramide, erythromycin, hyoscine, orlistat, green tea extracts, Astragalus, St John's Wort)
- •- epilepsy
- •- coronary heart disease, heart attack or failure, stroke or respiratory disease (COPD, cystic fibrosis)
- •- any other significant illness as assessed by the investigator
- •- intake of > 20 g alcohol on a daily basis
- •- smokers (cigarettes, cigars, marijuana)
- •- donation of blood (either through Red Cross or research activities) in the 12 weeks prior to enrolment in the study. Participants will also be instructed to abstain from donating blood for 12 weeks after study completion. A screening blood sample will be taken to ensure that only individuals with normal haemoglobin and iron levels are included in the study.
- •- consumption of a vegetarian diet
- •- inability to comprehend study protocol
- •- known lactose intolerance, intolerance, allergy to vildagliptin
- •- liver function tests and creatinine clearance outside the following ranges
- •Alanine aminotransferase (ALT)0 -55 U/l
- •Alkaline phosphatase30 - 110 U/l
- •Aspartate transaminase0 - 45 U/l
- •Bilirubin6 - 24 mmol/l
- •Calculated creatinine clearance will be determined as follows:
- •Cr clearance = [140 - age (years) x weight (kg)] / serum creatinine (micro mol/L)
- •Creatinine clearance cut-off of <50 ml/min AND/OR serum creatinine concentration >0.12mmol/l will be excluded.
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