Can Postprandial Reactive Hypoglycaemia be Reduced in Patients After Roux-en-Y Gastric Bypass With a Low Carbohydrate Diet?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Nadir plasma glucose
研究概览
简要总结
Roux-en-Y gastric bypass (RYGB) accelerates nutrient delivery to the small intestine causing higher peak blood glucose concentration early after meal intake. In the late postprandial period (1 1⁄2-2 h) nadir blood glucose level is lower compared with before operation. In some patients, overt postprandial hypoglycaemia develops, and is typically reported as a complication 1-5 years postoperatively, when maximal weight loss has been obtained. The pathophysiology of postprandial hypoglycaemia involves inappropriate hyper-secretion of insulin associated with exaggerated secretion of the gut hormone glucagon-like peptide-1 (GLP-1) leading to a mismatch between glucose absorption rate, insulin secretion and whole body glucose disposal. We hypothesize that lowering carbohydrate content of meals reduces postprandial glucose excursions whereby GLP-1 and insulin secretion is reduced and reactive hypoglycemia prevented.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •RYGB operated patients more than 12 month after operation
- •Stable in weight for at least 3 months (+/- 3 kg)
- •Plasma glucose below 3.4 mmol/L after screening with test meal (Fresubin drink) or with continuous glucose monitoring
排除标准
- •Fasting plasma glucose concentration > 7mmol/L
- •Critical illness
- •Hgb < 6.5 mM
- •Pregnancy or breastfeeding
结局指标
主要结局
Nadir plasma glucose
时间窗: 0-240 min, 240-480 min
Between low carbohydrate meal and standard meal.
次要结局
- Time to nadir glucose(0-240 min, 240-480 min)
- Time below basline glucose concentrations(0-480 min)
- Glycemic excursions(0-480 min)
- Peak plasma glucose(0-240 min, 240-480 min)
- Time to peak glucose(0-240 min, 240-480 min)
- Postprandial incremental glucose area(0-240 min, 240-480 min)
- Postprandial decremental glucose area(0-240 min, 240-480 min)
- Postprandial incremental insulin area(0-240 min, 240-480 min)
- Postprandial incremental GLP-1 area(0-240 min, 240-480 min)
研究者
Amirsalar Samkani
PhD-Student
Bispebjerg Hospital