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临床试验/NCT02176096
NCT02176096已完成不适用

Comparison of the Effect of a Novel Starch (Glycosade) Versus Gastrostomy Tube-Dextrose Infusion on Overnight Euglycaemia Control in Children With Glycogen Storage Disease Type I: Open Label Demonstration Trial

University of Manitoba2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2014年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
4
试验地点
2
主要终点
Normal Blood Glucose

研究概览

简要总结

The objective of this demonstration project is to compare a novel long-acting starch, Glycosade, a hydrothermally processed high amylopectin maize starch, versus gastrostomy tube-dextrose infusion in maintaining euglycaemia overnight in children with GSD-I. Glycosade has been reported to increase the duration of euglycaemia. Its slow release and longer periods of normal blood sugar achieved would preclude the need for the overnight dextrose infusion and eliminate the need for the surgical insertion of a gastrostomy tube for this purpose. Glycosade also reportedly causes fewer gastrointestinal side effects, thus potentially improving compliance to therapy. The investigators intend to evaluate Glycosade in our patients and determine its efficacy on glucose control, on the length of normoglycemia achieved and to determine if there are reduced side effects in our patients with GSD-I. This will be accomplished by an open label study of Glycosade in GSD-I patients who consent to the protocol.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
5 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of GSD Type 1
  • Age >5 years

排除标准

  • 未提供

研究组 & 干预措施

Glycosade

Experimental

干预措施: Glycosade (Dietary Supplement)

结局指标

主要结局

Normal Blood Glucose

时间窗: Overnight

With the use of Glycosade blood glucose would be maintained for 8 hours.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Aizeddin (Aziz) Mhanni

Associate Professor, Department of Pediatrics and Child Health

University of Manitoba

研究点 (2)

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