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临床试验/NCT07739394
NCT07739394尚未招募不适用

Diazoxide in the Treatment of Type 1 Glycogenosis

Central Hospital, Nancy, France0 个研究点目标入组 15 人开始时间: 2026年8月30日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
15
主要终点
evolution of glycemia and lactic acid

研究概览

简要总结

In children with a glycogen storage disorder, one of the enzymes needed to convert glucose into glycogen, or to break down glycogen into glucose, is missing. There are many different types of glycogen storage disorders (also known as glycogenoses).

Type 1 glycogenosis results in low blood sugar (hypoglycemia), increased lactate (a glucose metabolite produced by body tissues when oxygen supply is insufficient) and a bulky abdomen (glycogen accumulation induces liver enlargement). Low blood sugar leads to sweating, confusion, convulsions and coma. Type 1 glycogenosis manifests itself early in life.

In children, glycogen storage disorders can have other consequences, such as stunted growth linked to chronic acidosis, tend to increase uric acid levels (a breakdown product) which accumulate in the joints, leading to gout, and in the kidneys, leading to kidney stones.

The mainstay of treatment is frequent oral feeding with raw cornstarch or a lactose-free preparation with maltodextrin to maintain normal blood sugar levels. Nocturnal enteral feeding via gastrostomy is necessary during the first years of life.

These children tend to have greater insulin reactions (= hormone that brings sugar into the cells), resulting in a more rapid fall in blood sugar levels.

Diazoxide is a drug that inhibits pancreatic insulin secretion and prevents blood sugar levels from falling. It has been used successfully in some patients.

The main objective of this project is to describe the metabolic balance in children with type 1 glycogenosis treated with Diazoxide compared with children who did not receive Diazoxide treatment.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients followed at the CHRU de Nancy or CHU de Besançon for type I glycogen storage disease
  • Person having received full information on the organization of the research and not having objected to the use of this data
  • Parental consent for minors

排除标准

  • Lack of data in medical records to meet the study's main objective

结局指标

主要结局

evolution of glycemia and lactic acid

时间窗: From diagnosis to 10 years of follow-up (based on available data)

次要结局

未报告次要终点

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Sponsor

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Diazoxide in the Treatment of Type 1 Glycogenosis | 临床试验