Paediatrics Publications

Title

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

Authors

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 CentreFollow
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

Journal

BMJ Open

Volume

5

Issue

5

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.

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