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临床试验/ACTRN12621001527853
ACTRN12621001527853招募中未知

Specialised Dietary Fibre Intervention in Children with Type 1 Diabetes - is it safe, feasible and tolerable?

Queensland Children's Hospital0 个研究点目标入组 30 人开始时间: 2021年11月10日最近更新:
适应症

试验速览

阶段
未知
状态
招募中
发起方
入组人数
30

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
5 Years 至 14 Years(—)
性别
All

入选标准

  • Children and adolescents aged 5 – 14 years (inclusive) with T1D that was diagnosed at least 3 months prior to entry into the study
  • - HbA1c less than or equal to 9% (75 mmol/mol) at the time of entry into the study
  • - BMI between 15th centile and 85th centile, inclusive
  • - The child/adolescent and their family are willing and able to follow the study protocol

排除标准

  • - Concomitant disease or treatment that may, in the judgement of the investigators, impact on glycaemic control, insulin requirements or other outcome measures
  • - Hypoglycaemia unawareness
  • - History or symptoms of malabsorption or gastrointestinal disease, including coeliac disease
  • - Known liver or renal disease
  • - On a restricted or special diet that would impact their ability to take the supplement e.g. intermittent fasting or ketogenic diet
  • - Use of medication other than insulin that affects glucose homeostasis
  • - Antibiotic usage within the six weeks prior to entry into the study or anticipated usage during the study

研究者

发起方
Queensland Children's Hospital

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