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The Celiac Disease and Diabetes-Dietary Intervention and Evaluation Trial (CD-DIET) protocol: A randomised controlled study to evaluate treatment of asymptomatic coeliac disease in type 1 diabetes
BMJ Open
  • Farid H. Mahmud, Hospital for Sick Children University of Toronto
  • Emilia N. De Melo, Hospital for Sick Children University of Toronto
  • Karima Noordin, Hospital for Sick Children University of Toronto
  • Esther Assor, Hospital for Sick Children University of Toronto
  • Kamaljeet Sahota, Hospital for Sick Children University of Toronto
  • Jolie Davies-Shaw, Hospital for Sick Children University of Toronto
  • Ernest Cutz, Hospital for Sick Children University of Toronto
  • Gino Somers, Hospital for Sick Children University of Toronto
  • Margaret Lawson, Children's Hospital of Eastern Ontario, Ottawa
  • David R. Mack, Children's Hospital of Eastern Ontario, Ottawa
  • Patricia Gallego, London Health Sciences Centre
  • Charlotte McDonald, London Health Sciences Centre
  • Melanie D. Beaton, London Health Sciences Centre
  • Kevin Bax, London Health Sciences Centre
  • Fred Saibil, Sunnybrook Health Sciences Centre
  • Jeremy Gilbert, Sunnybrook Health Sciences Centre
  • Susan Kirsch, Markham Stouffville Hospital
  • Bruce A. Perkins, University Health Network University of Toronto
  • Maria Cino, University Health Network University of Toronto
  • Eva Szentgyorgyi, University Health Network University of Toronto
  • Dror Koltin, Trillium Health Partners
  • Amish Parikh, Trillium Health Partners
  • Geetha Mukerji, Women's College Hospital
  • Andrew Advani, Saint Michael's Hospital University of Toronto
  • Olivia Lou, Juvenile Diabetes Research Foundation-Canadian Clinical Trials Network ( JDRF-CCTN)
  • Margaret A. Marcon, Hospital for Sick Children University of Toronto
Document Type
Article
Publication Date
1-1-2015
URL with Digital Object Identifier
10.1136/bmjopen-2015-008097
Abstract

Introduction: 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. Methods and analysis: 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. Ethics and dissemination: 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. Trial registration number: NCT01566110.

Citation Information
Farid H. Mahmud, Emilia N. De Melo, Karima Noordin, Esther Assor, et al.. "The Celiac Disease and Diabetes-Dietary Intervention and Evaluation Trial (CD-DIET) protocol: A randomised controlled study to evaluate treatment of asymptomatic coeliac disease in type 1 diabetes" BMJ Open Vol. 5 Iss. 5 (2015)
Available at: http://works.bepress.com/kevin-bax/5/