ACTRN12610001104044尚未招募4 期
Does dipeptidyl peptidase IV (DPP-IV) inhibition (vildagliptin) potentiate the effects of intraduodenal fat on glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP), and thereby reduce energy intake and postprandial triglycerides, and increase energy expenditure and fat oxidation in healthy lean males?
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 16
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 55 Years（—）
- 性别
- Male
入选标准
- •Normal body weight for height (BMI: 19 - 25 kg/m2),
- •Aged 18-55
排除标准
- •Each participant will be questioned at a screening visit prior to their enrolment in the study to exclude:
- •significant gastrointestinal symptoms; disease or surgery
- •current use of any prescribed or non-prescribed medications
- •diabetes mellitus
- •cardiovascular or respiratory disease
- •any other significant illness as assessed by the investigator
- •allergy to local anaesthetic
- •intake of > 20 g alcohol on a daily basis
- •smokers (cigarettes, cigars, marijuana)
- •restrained eaters, as determined by a score of > 12 on the eating restraint component of the Three Factor Eating Questionnaire.
- •donation of blood 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
- •high performance athletes
- •claustrophobia in confined spaces
- •unable to comprehend study protocol
- •known lactose intolerance
- •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 (micromol/L)
- •Subjects with a creatinine clearance cut-off of <50 ml/min AND/OR serum creatinine concentration >0.12mmol/l will be excluded.
研究者
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