A Randomized Controlled Trial to Evaluate the Efficacy and Safety of a Gluten-Free Diet in Patients With Asymptomatic Celiac Disease and Type 1 Diabetes, Celiac Disease and Diabetes - Dietary Intervention and Evaluation Trial (CD-DIET)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 8
- 主要终点
- Metabolic Control
研究概览
简要总结
Currently no consensus exists on the optimal way to manage asymptomatic patients with celiac disease (CD) and Type 1 diabetes (T1D). The impact of dietary treatment as it pertains to clinically relevant outcomes such as metabolic control, bone mineralization and wellbeing will be evaluated in this study. A randomized controlled study longitudinally evaluating HbA1c and glycemic excursions using continuous glucose monitoring will rigorously determine the impact of a gluten-free diet (GFD) on blood glucose variability in patients with T1D.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet each of the following criteria for inclusion into the study:
- •Males and females age between 8 and 45 years.
- •Diagnosis of T1D by American Diabetes Association (ADA) criteria with duration of T1D greater than 1 year.
- •CD screen positive (Positive TTG serology).
- •Presence of a positive duodenal biopsy for CD (Marsh score of 2 or greater).
- •Ability of the subject or a legally authorized representative to speak and read English or French.
- •Ability of the subject to participate in all aspects of this clinical trial.
- •Written informed consent must be obtained and documented, with assent of the child if <14 years of age.
排除标准
- •Prior diagnosis of CD.
- •Symptoms or other evidence of overt CD defined by at least one of:
- •CD symptoms using the Gastrointestinal Symptom Scale [GISS]
- •Impaired growth
- •Presence of recurrent apthous ulcers (painful mouth ulcers involving mucous membranes) or dermatitis herpetiformis (blistering skin rash). Mouth or skin lesions known to be related to diagnosed herpes are not included in this exclusion criteria.
- •Conditions which in the opinion of the investigator may interfere with the subject's ability to participate in the study.
- •Prior enrolment in the current study.
- •Concurrent enrolment in a longitudinal intervention study.
- •Previously diagnosed or treated osteoporosis.
- •Pregnancy or lactation.
研究组 & 干预措施
Diet Intervention Group
干预措施: Gluten Free Diet (Dietary Supplement)
Control Group
Subjects assigned to the control group will continue their usual diet. They will receive dietary teaching at each study visit as part of their diabetes management.
结局指标
主要结局
Metabolic Control
时间窗: Change from Baseline over 1 year
As a standard measure of diabetes control, HbA1c is assessed on a frequent and regular basis as recommended by the CDA 2008 guidelines in both pediatric and adult patients. HbA1c is synthesized throughout the cycle of a red blood cell and reflects the degree of chronic hyperglycemia present in patients with diabetes.
次要结局
- Continuous Glucose Monitoring(Baseline, 6 months and 12 months after randomization)
- Hypoglycemic Episodes(Frequency over 12 months)
研究者
Farid Mahmud
Staff Physician
The Hospital for Sick Children