Low-carbohydrate Diet in Paediatric Type 1 Diabetes: Effects on Glycaemic Control and Islet Autoimmunity
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Change in continuous glucose monitoring time in target range (3.9-10.0 mmol/l) during the LCD period compared to the RCD period
研究概览
简要总结
The primary aim of this pilot study is to test whether low-carbohydrate diet (LCD) instituted in children/adolescents with type 1 diabetes (T1D) can improve their disease control. The primary objective of the trial is the change in continuous glucose monitoring time in target range 3.9-10.0 mmol/l (TIR) in a 5-week period on LCD as opposed to a 5-week period on recommended carbohydrate diet (RCD).
Secondary objectives are:
Changes in immune parameters during the LCD period; Differences in fecal microbiome during the LCD period; Differences in fecal, serum and urine metabolome during the LCD period;
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •T1D diagnosed according to the ADA (American Diabetes Assocciation) criteria
- •T1D duration for at least 1 year prior to the intervention
- •continuous glucose monitor (CGM) worn > 70% time in the month prior to the intervention
排除标准
- •last HbA1c < 40 or > 70 mmol/mol
- •subject has celiac disease
- •daily average carbohydrate intake < 130 g/day from 14 days food record prior to the intervention
- •any concomitant disease possibly affecting glucose control
- •any chronic medication possibly affecting glucose control
结局指标
主要结局
Change in continuous glucose monitoring time in target range (3.9-10.0 mmol/l) during the LCD period compared to the RCD period
时间窗: Month 1 - Month 24
次要结局
- Changes in mean body weight standard deviation score during the LCD period compared to the RCD period(Month 1 - Month 24)
- Changes in muscle strength measured by jumping mechanography during the LCD period compared to the RCD period(Month 1 - Month 24)
- Changes in the lipid spectrum during the LCD period compared to the RCD period(Month 1 - Month 24)
- Differences in faecal microbiome between the LCD and RCD periods(Month 1 - Month 36)
- Differences in serum metabolome between the LCD and RCD periods(Month 1 - Month 36)
- Differences in urine metabolome between the LCD and RCD periods(Month 1 - Month 36)
- Changes in mean insulin dose during the LCD period compared to the RCD period(Month 1 - Month 24)
- Differences in faecal metabolome between the LCD and RCD periods(Month 1 - Month 36)
- Changes in lymphocyte subgroup cell counts (flow cytometry) during the LCD period(Month 1 - Month 36)
研究者
Zdeněk Šumník
Prof.
University Hospital, Motol