ACTRN12621001599864招募中未知
Effects of Roux-en-Y gastric bypass on gastric emptying and small intestinal transit of solid and liquid meal components – relationship to effects on appetite and gastrointestinal hormones
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 15
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
- Non-randomised trial
- 主要目的
- Diagnosis
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 65 Years(—)
- 性别
- All
入选标准
- •Male and/or female participants aged 18 – 65 years, who have had Roux-en-Y gastric bypass surgery at least 6 months previously
排除标准
- •Use of any medication that may influence gastrointestinal motor function that cannot be withheld for the study (e.g. GLP-1 receptor agonists, acarbose, opiates, anticholinergics, levodopa, clonidine, nitrates, phosphodiesterase type 5 inhibitors, sumatriptan, metoclopramide, domperidone, prucalopride, or erythromycin)
- •Uncontrolled diabetes (HbA1c >7.5%)
- •Evidence of drug abuse, consumption of more than 20 g alcohol or 10 cigarettes on a daily basis
- •History of chronic gastrointestinal disease (inflammatory bowel disease, coeliac disease) or prior gastrointestinal surgery (other than other than bariatric surgery, uncomplicated appendicectomy or cholecystectomy)
- •History of epilepsy
- •History of severe respiratory, cardiovascular, hepatic and/or renal disease (severe in that the social or physical manifestation of the disease, or living with the condition, impact negatively and significantly on the individuals’ ability to lead a normal day to day life).
- •Impaired renal (as assessed by calculated creatinine clearance < 90 mL/min, iron status, or liver function tests outside the following ranges:
- •-Alanine aminotransferase (ALT) >3x ULN
- •-Aspartate transaminase (AST) >3x ULN
- •-Alkaline phosphatase (ALP) >3x ULN
- •-Bilirubin >24 mmol/L
- •-Ferritin <15 ng/mL (Females), <30 ng/mL (Males)
- •-Haemoglobin <115 g/L (Females), <13 g/L (Males)
- •Donation of blood within the previous 3 months
- •Participation in any other research studies within the previous 3 months that requires blood sampling
- •Exposure to ionising radiation >3mSv for research purposes within the past 12 months
- •Vegetarian
- •Inability to give informed consent
- •Female participants who are pregnant or planning for pregnancy, or are lactating
研究者
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