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临床试验/NCT06699485
NCT06699485尚未招募不适用

Short-term Effects of Carbohydrate-restricted Diet on Glycemic and Metabolic Control Among Children and Adolescent With Type 1 Diabetes Mellitus

Sohag University1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2025年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
25
试验地点
1
主要终点
The blood glucose level

研究概览

简要总结

The current management of type 1 diabetes mellitus (T1DM) involves the use intensive insulin therapy, frequent blood glucose monitoring and carbohydrate counting.

There is a need to strengthen some of the T1DM management aspects as dietary intervention in order to achieve better glycemic and metabolic control.

The international society for pediatric and adolescent diabetes (ISPAD) recommend that children and adolescents with T1DM have about 50% of their total daily caloric requirement from carbohydrates. However, an alternative approach is emerging in recent years. The use of low-carbohydrate diet is suggested to reduce postprandial hyperglycemia and glycemic variability and lower the required insulin.

研究设计

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

入排标准

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

入选标准

  • •Children and adolescents aged 10 - 18 years, diagnosed with T1DM for at least 1 year attending the Pediatric diabetes clinic at Sohag University Hospital and using the MDI regimen and carbohydrate counting methods are eligible for the study.

排除标准

  • •Children and adolescents with associated diseases such as autoimmune hypothyroidism or celiac disease and those with diabetes-related complications such as diabetic neuropathy, retinopathy or nephropathy will be excluded.

研究组 & 干预措施

Group 1

Experimental

Children and adolescents aged 10 - 18 years, diagnosed with T1DM for at least 1 year

干预措施: Low carb diet (Dietary Supplement)

结局指标

主要结局

The blood glucose level

时间窗: 6 months

The blood glucose levels will be measured for the study participants by finger-stick glucometer

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

Hadeer Soliman Kamaleldin

Resident of pediatric department

Sohag University

研究点 (1)

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