Diet Intervention in Newly Diagnosed Children With Type 1 Diabetes. How to Prolong Remission Using a Non-medical Approach?
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 20
- 主要终点
- C-peptide change from baseline to 12 months follow-up
研究概览
简要总结
Type 1 diabetes (T1D) emerge when the auto-immune destruction exceeds the beta cell's regenerative capacity. The patients' beta-cell capacity increases shortly after onset when glucotoxicity decreases after the start of insulin therapy. Children have fewer beta cells and therefore shorter remission; but the expansion potential is larger the younger the child is. The problem with the majority of intervention studies is the many and serious side effects, or a quite marginal effect on the residual beta-cell function. However, in animals that had received gluten-free diet, the T1D incidence fell from 61% to only 6%. Gluten-free diet increases the number of regulatory T cells in Peyer's patches, affect the composition of intestinal microflora and modify the balance between pro and anti-inflammatory cytokines in T cells. Therefore, the aim of our study is to prolong the remission phase by introducing a gluten-free diet intervention to children at T1D onset.
详细描述
Introduction Type 1 diabetes (T1D) is characterised by a progressive loss and destruction of beta cells. The optimal timing of intervention is during remission when the beta cells regenerative power is still present, because we are treating only already diseased children, and there are enough beta cells to improve outcome if the cells survive.
Thus, the overall aim of this study is to prolong the remission phase by introducing glutenfree diet intervention to children with T1D and in addition, investigate the role of physical activity/fitness.
Hypothesis:
- Gluten-free diet leads to a shift in balance between the destruction and the regenerative capacity as well as increases insulin sensitivity.
- The diet have an impact on the gut microbiome composition and projected function, metabolic, immune and inflammatory biomarkers.
This is the first study with a non-pharmacological intervention in children combining both factors with a potential effect on the immune system as well as on insulin sensitivity and the first to include dietary factors, measures of physical fitness and measures of inflammation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed with type 1 diabetes (duration < 3 month)
排除标准
- •Diabetes duration > 3 months,
- •not type 1 diabetes
结局指标
主要结局
C-peptide change from baseline to 12 months follow-up
时间窗: 12 months
Stimulated C-peptide
Insulin Adjusted HbA1c change from baseline to 12 months follow-up
时间窗: 12 months
4\*insulin + HbA1c (%)
Insulin per kg from baseline to 12 months follow-up
时间窗: 12 months
total insulin dose per day
次要结局
- Microbiota (feces samples) change from baseline to 6 months follow-up(6 months)
- Immune system (Th1 and Th2 cytokines) change from baseline to 12 months follow-up(12 months)