NCT02372526Unknown不适用
The Effect of Different Macronutrients on Gastrointestinal Hormone Secretion After Gastric Bypass Operation
Kirstine Nyvold Bojsen-Moeller1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2015年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Within group difference in Glucagon-like Peptide 1 secretion (evaluated by iAUC).
研究概览
简要总结
The purpose of this study is to determine the type of macronutrient (carbohydrate, lipid or protein) that most potently stimulates the endogen secretion of different gut hormones (primary outcome = Glucagon-Like peptide-1) in gastric bypass operated patients. The study also includes a comparison of the secretion of gut hormones after oral intake of lipid with or without a pancreatic lipase inhibitor.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Underwent RYGB surgery more than 18 months earlier, weight stabile (+/- 5 kg during 1 month)
排除标准
- •Inadequate thyroid substitution, undergoing treatment with drugs known to interact with Orlistat (such as cyclosporine, anticoagulating agents, amiodarone, amlodipine and epileptics), where pausing the treatment with these is not an option. Type 1 or 2 diabetes mellitus now or prior to RYGB operation. Serious heart or respiratory illness. Haemoglobin levels below 6,5 mM.
- •Healthy control subjects:
- •Inclusion Criteria:
- •Have not underwent bariatric surgery.
- •Exclusion Criteria:
- •Inadequate thyroid substitution, undergoing treatment with drugs known to interact with Orlistat (such as cyclosporine, anticoagulating agents, amiodarone, amlodipine and epileptics), where pausing the treatment with these is not an option. Type 1 or 2 diabetes mellitus now or prior. Serious heart or respiratory illness. Haemoglobin levels below 6,5 mM.
结局指标
主要结局
Within group difference in Glucagon-like Peptide 1 secretion (evaluated by iAUC).
时间窗: Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240
I.e. Comparison of GLP-1 secretion (iAUC) as a result of intake of different macronutrients between a) gastric bypass patients only b) healthy volunteers only.
次要结局
- Within group difference in Ghrelin secretion (evaluated by iAUC).(0, 30, 45, 60, 120, 180, 240)
- Within group difference in Changes in glycerol, triacylglycerol and free fatty acids.(0, 30, 45, 60, 120, 180, 240)
- Within group difference in Insulin secretion (evaluated by iAUC).(2xBasline, 0, 10, 15, 20, 30, 40, 45, 60, 90, 120, 180, 240)
- Within group difference in Heart rate (bpm).(2xBasline, 0, 5, 10, 15, 20, 25, 30, 40, 45, 60, 90, 120, 180, 240)
- Within group difference in Blood pressure (mmhg).(0, 15, 30, 45, 60, 90, 120, 180, 240)
- Within group difference in Peptide YY 3-36 secretion (evaluated by iAUC).(Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240)
- Within group difference in Glucose-dependent insulinotropic peptide secretion (evaluated by iAUC).(Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240)
- Within group difference in Plasma glucose concentration.(2xBasline, 0, 5, 10, 15, 20, 25, 30, 40, 45, 60, 90, 120, 180, 240)
- Within group difference in Ad libitum food intake (grams).(240)
- Within group difference in Glucagon secretion (evaluated by iAUC).(Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240)
- Within group difference in Cholecystokinin secretion (evaluated by iAUC).(Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240)
- Within group difference in Changes in bile acids.(0, 30, 45, 60, 120, 180, 240)
- Within group difference in Visual Analog Scale.(0, 30, 60, 90, 120, 180, 240)
研究者
Kirstine Nyvold Bojsen-Moeller
Postdoc
Hvidovre University Hospital
研究点 (1)
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