The Effect of Gluten-free Diet on Residual Beta-cell Capacity, Immune Function and Gut Microbiome in Children With Newly Diagnosed Type 1 Diabetes (T1D)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 4
- 主要终点
- Change in C-peptide Area Under the Curve Measured by Mixed-meal Tolerance Test (MMTT) Between Group on GFD and Standard Gluten-containing Diet.
研究概览
简要总结
The primary aim of this pilot study is to test whether gluten-free diet (GFD) instituted in children shortly after onset of Type 1 Diabetes (T1D) can decelerate the decline in beta cell function as compared to age matched controls. Primary objective of the trial is the change in C-peptide area under the curve measured by mixed-meal tolerance test (MMTT) between group on GFD and standard gluten-containing diet.
Secondary objectives are:
- Changes in immune parameters between gluten-free diet group and control group;
- Differences in fecal microbiome between children on normal diet and children on GFD;
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 Diabetes (T1D) diagnosed according to the American Diabetes Association criteria
排除标准
- •negativity of the three diabetes-related autoantibodies at T1D onset;
- •negativity of celiac-disease high risk Human Leucocyte Antigen DQB1 (HLA-DQB1) and Human Leucocyte Antigen DQA1 (HLA-DQA1) genotype HLA-DQB1*03:02-DQA1*03 nor DQB1*02-DQA1*05 molecules;
- •celiac disease or positive transglutaminase antibody test;
- •body mass index over two standard deviations of the age and height standard;
- •any concomitant disease potentially influencing immune response or gluten sensitivity
结局指标
主要结局
Change in C-peptide Area Under the Curve Measured by Mixed-meal Tolerance Test (MMTT) Between Group on GFD and Standard Gluten-containing Diet.
时间窗: Month 1 (baseline) - Month 12 (end of intervention)
Area under the curve of C-peptide in MMT test at 0, 30, 60, 90 and 120 minutes.
次要结局
- Changes in Mean HbA1c at 6 and 12 Months Relative to Baseline at Month 1.(Month 1 (baseline) - Month 6 - Month 12 (end of intervention))
- Changes in Mean Insulin Dose at 6 and 12 Months Relative to Baseline at Month 1.(Month 1 (baseline) - Month 6 - Month 12 (end of intervention))
- Changes in Immunological Parameters (FoxP3 Tregs, Th1 and Th17 Counts) at 12 Months Relative to Baseline at Month 1.(Month 1 (baseline) - Month 12 (end of intervention))
- Differences in Fecal Microbiome Between Children on Normal Diet and Children on Gluten-free Diet Over the First Year of Diabetes Duration(Month 1 (before intervention) - Pooled values throughout the intervention (months 3-12) - Month 15 (after intervention))
研究者
Zdeněk Šumník
MD, PhD
University Hospital, Motol