Investigation Whether a Gluten Free Diet After the Onset of Type 1 Diabetes (T1D) Can Better Preserve the Remaining Beta Cell Mass and at the Same Time Prevent the Development of Celiac Disease (CD) in These Patients.
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Preservation of beta cells function
研究概览
简要总结
The overall aim of this project is to investigate whether a gluten free diet after the onset of type 1 diabetes (T1D) can better preserve the remaining beta cell mass and at the same time prevent the development of Celiac Disease (CD) in these patients.
Specific aims
• To study whether gluten free diet during one year after the onset of diabetes influence the appearance and duration of clinical remission in children with Type 1 diabetes.
New data show that a gluten free diet is beneficial concerning the insulin production after the onset of diabetes. The investigators want to investigate if gluten is a triggering protein for the destruction of the beta cell function after the onset of diabetes by comparing children who have a normal diet compared to children with a gluten free diet during one year after the onset of the disease.
- To study whether a gluten free diet during one year after the onset of diabetes prevent the development of Celiac Disease in these children and the impact of having two diseases It is known that it is almost 10 times more common that children with Type 1 Diabetes (IDDM) develop Celiac Disease (CD) than the general population and that most of these children (6-7 %) develop CD after the onset of Diabetes and within 5 years. Based on our new data that CD is preventable to some extent the investigators plan to perform randomized controlled studies if it is possible to prevent or postpone CD by means after the onset of IDDM.
- To investigate the impact of gluten free diet on the regulation of autoimmune responses The investigators will test the hypothesis that gluten free diet in children with recent onset T1D will implement immune regulation and inhibit the activation of potentially autoreactive T cells.
详细描述
General project outline Our aim is to perform a intervention study whether one year gluten free diet in children with newly diagnosed TID would make it possible to influence the speed of the beta-cells destruction and if this diet decrease the risk to develop CD after the disease A power calculation shows that we would need 600 participants to detect clinically relevant effects (see power calculation). As the power calculation is based on estimated effects we plan to first perform a pilot study including 100 patients. Based on the results of the pilot study we then plan to continue to design a larger study to get more robust information.
All children will also at the start study and, after 1 and 2 years receive a KID-screen form to study the quality of life of time in children with diabetes and to compare children with diabetes without CD and to them who will develop or have undiagnosed CD. Furthermore all children will also be monitored by a dietician during the study period, at onset, after 1 and 2 years according to the content (protein, fat, carbohydrate, gluten and vitamins) during the study.
Population Consecutive patients with recent onset of diabetes at Swedish paediatric clinics are given information about the study and they and their parents are asked to participate in the trial.
Informed consent given by patients and guardians/parents and inclusion criteria are; 1. Type 1 diabetes according to the ADA classification with < 1 months diabetes duration at time of screening 2. Age 3.00 -17.99 years at time of screening 3. Fasting C-peptide at time of screening ≥ 0.12 nmol/L Exclusion Criteria
- Inability or unwillingness to comply with the provisions of this protocol
- Deemed by the investigator not being able to follow instructions and/or follow the study protocol Recruitment and Screening Eligible subjects and their parent(s) / guardian(s) will have the study explained to them, and will receive a written patient information. If, after this, the subjects agree to participate, they will personally sign and date the written informed consent form. In accordance with the Declaration of Helsinki, the investigator must explain to the patient that they have the right to withdraw from the study at any time, and that this will in no way prejudice their future treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes according to the ADA classification with < 1 months diabetes duration at time of screening
- •Age 3.00 -17.99 years at time of screening
- •Fasting C-peptide at time of screening ≥ 0.12 nmol/L
排除标准
- •Inability or unwillingness to comply with the provisions of this protocol
- •Deemed by the investigator not being able to follow instructions and/or follow the study protocol
- •NB: new ethical approval will be applied for children between 1-3 years of age
结局指标
主要结局
Preservation of beta cells function
时间窗: within 2years after the onset of type 1 diabetes
Differences in c-peptide production between the Groups A and B, 12 and 18 months after the onset of diabetes.
次要结局
- Prevention of Celiac DIsease(Five years after the onset of Diabetes)
研究者
Annelie Carlsson
Associate Professor
Lund University