New Approaches for Over-night Feeding in Glycogen Storage Disease Type 1 (GSD 1)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Maximum fasting time over-night (h)
研究概览
简要总结
In this clinical cross-over study, we will compare the efficacy of different oral nutrition regimens for night-time glucose control in adult GSD 1 patients. Three different over-night nutrition regimens (=interventions) will be compared in each patient sequentially, (1) uncooked corn starch (UCSS, "Maizena"), (2) modified corn-starch, (3) other carbohydrate (starch) containing meal. During each intervention, glucose profiles will be continuously monitored by continuous glucose monitoring (CGMS). The duration of each intervention is 3d (mimimum) to 6d (maximum), depending on the quality of night-time glucose control and the technical quality of glucose sensor readings. Between the interventions, the patients follow their normal prescribed diet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Glycogen storage disease type 1 (type 1a and 1b)
- •Stable nighttime glucose control without frequent or severe hypoglycaemia under current dietary treatment, according to capillary glucose measurements.
排除标准
- •Unstable night-time glucose control during the last 8 weeks with frequent (> 4x weekly) hypoglycaemia during night-time, or a hospitalisation due to unstable glucose control during the last 4 weeks, or any episode of severe hypoglycaemia (requiring assistance or loss of consciousness) during the last 4 weeks.
- •Pregnancy or breast feeding
- •Drug or alcohol abuse
- •Acute gastrointestinal problems (e.g. acute gastroenteritis)
- •Known malignancy (e.g. hepatocellular carcinoma)
研究组 & 干预措施
uncooked corn starch
Patients receive uncooked corn starch before bed-time
干预措施: overnight nutrition regime (Other)
modified corn starch
Patients receive modified corn starch before bed-time
干预措施: overnight nutrition regime (Other)
other carbohydrate (starch) containing meal
Patients receive a carbohydrate (starch) containing meal before bed-time
干预措施: overnight nutrition regime (Other)
结局指标
主要结局
Maximum fasting time over-night (h)
时间窗: Maximum fasting time will be measured during each dietary intervention for an average period of 3d (minimum) to 6d (maximum)
次要结局
未报告次要终点