Mahmud Farid H, De Melo Emilia N, Noordin Karima, Assor Esther, Sahota Kamaljeet, Davies-Shaw Jolie, Cutz Ernest, Somers Gino, Lawson Margaret, Mack David R, Gallego Patricia, McDonald Charlotte, Beaton Melanie D, Bax Kevin, Saibil Fred, Gilbert Jeremy, Kirsch Susan, Perkins Bruce A, Cino Maria, Szentgyorgyi Eva, Koltin Dror, Parikh Amish, Mukerji Geetha, Advani Andrew, Lou Olivia, Marcon Margaret A
Department of Pediatrics, Division of Endocrinology, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.
Department of Pathology, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.
BMJ Open. 2015 May 11;5(5):e008097. doi: 10.1136/bmjopen-2015-008097.
Coeliac disease (CD) is an autoimmune condition characterised by gluten-induced intestinal inflammation, and observed at a 5-10 fold greater prevalence in type 1 diabetes. While universal screening for CD in patients with diabetes is frequently advocated, objective data is limited as to benefits on diabetes control, bone health or quality of life related to the adoption of a gluten-free diet (GFD) in the large proportion of patients with diabetes with asymptomatic CD. The Celiac Disease and Diabetes-Dietary Intervention and Evaluation Trial (CD-DIET) study is a multicenter, randomised controlled trial to evaluate the efficacy and safety of a GFD in patients with type 1 diabetes with asymptomatic CD.
Children and adults (8-45 years) with type 1 diabetes will be screened for asymptomatic CD. Eligible patients with biopsy-proven CD will be randomly assigned in a 1:1 ratio to treatment with a GFD for 1 year, or continue with a gluten-containing diet. The primary outcome will evaluate the impact of the GFD on change in glycated haemoglobin. Secondary outcomes will evaluate changes in bone mineral density, blood glucose variability and health-related quality of life between GFD-treated and the regular diet group over a 1-year period. The study was initiated in 2012 and has subsequently expanded to multiple paediatric and adult centres in Ontario, Canada.
The findings from this study will provide high-quality evidence as to the impact of GFD treatment on glycaemic control and complications in asymptomatic children and adults with CD and type 1 diabetes.
NCT01566110.
乳糜泻（CD）是一种自身免疫性疾病，其特征为麸质诱导的肠道炎症，在1型糖尿病患者中的患病率高出5至10倍。虽然经常提倡对糖尿病患者进行CD的普遍筛查，但关于在大部分无症状CD的糖尿病患者中采用无麸质饮食（GFD）对糖尿病控制、骨骼健康或生活质量的益处，客观数据有限。乳糜泻与糖尿病——饮食干预与评估试验（CD-DIET）研究是一项多中心随机对照试验，旨在评估GFD对无症状1型糖尿病合并CD患者的疗效和安全性。
将对1型糖尿病儿童和成人（8至45岁）进行无症状CD筛查。经活检证实患有CD的符合条件的患者将按1:1的比例随机分配，一组接受GFD治疗1年，另一组继续含麸质饮食。主要结局将评估GFD对糖化血红蛋白变化的影响。次要结局将评估GFD治疗组和常规饮食组在1年期间骨密度、血糖变异性和健康相关生活质量的变化。该研究于2012年启动，随后已扩展至加拿大安大略省的多个儿科和成人中心。
本研究的结果将为GFD治疗对无症状CD合并1型糖尿病的儿童和成人的血糖控制及并发症的影响提供高质量证据。
NCT01566110。
