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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
  1. Farid H Mahmud1,
  2. Emilia N De Melo1,
  3. Karima Noordin1,
  4. Esther Assor1,
  5. Kamaljeet Sahota1,
  6. Jolie Davies-Shaw1,
  7. Ernest Cutz2,
  8. Gino Somers2,
  9. Margaret Lawson3,
  10. David R Mack4,
  11. Patricia Gallego5,
  12. Charlotte McDonald6,
  13. Melanie D Beaton7,
  14. Kevin Bax8,
  15. Fred Saibil9,
  16. Jeremy Gilbert10,
  17. Susan Kirsch11,
  18. Bruce A Perkins12,
  19. Maria Cino13,
  20. Eva Szentgyorgyi14,
  21. Dror Koltin15,
  22. Amish Parikh15,
  23. Geetha Mukerji16,
  24. Andrew Advani17,
  25. Olivia Lou18,
  26. Margaret A Marcon19
  1. 1Department of Pediatrics, Division of Endocrinology, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada
  2. 2Department of Pathology, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada
  3. 3Division of Endocrinology and Metabolism, Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada
  4. 4Division of Gastroenterology, Hepatology and Nutrition, Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada
  5. 5Division of Endocrinology Paediatrics, London Health Sciences Centre, London, Ontario, Canada
  6. 6Division of Endocrinology and Metabolism, St. Joseph Health Care, London Health Sciences Centre, London, Ontario, Canada
  7. 7Division of Gastroenterology, London Health Sciences Centre, London, Ontario, Canada
  8. 8Pediatric Gastroenterology, Department of Pediatrics, Children's Hospital, London Health Sciences Centre, London, Ontario, Canada
  9. 9Division of Gastroenterology, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
  10. 10Division of Endocrinology and Metabolism, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
  11. 11Division of Endocrinology, Markham Stouffville Hospital, Toronto, Ontario, Canada
  12. 12Division of Endocrinology and Metabolism, Department of Medicine, University Health Network, University of Toronto, Toronto, Ontario, Canada
  13. 13Division of Gastroenterology, Toronto Western Hospital, University Health Network, University of Toronto, Toronto, Ontario, Canada
  14. 14Department of Pathology, University Health Network, University of Toronto, Toronto, Ontario, Canada
  15. 15Division of Endocrinology, Trillium Health Partners, Mississauga, Ontario, Canada
  16. 16Division of Endocrinology, Women's College Hospital, Toronto, Ontario, Canada
  17. 17Division of Endocrinology, St. Michael's Hospital, Toronto, Ontario, Canada
  18. 18Juvenile Diabetes Research Foundation—Canadian Clinical Trials Network (JDRF-CCTN), Toronto, Ontario, Canada
  19. 19Division of Gastroenterology, Hepatology and Nutrition, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada
  1. Correspondence to Dr Farid H Mahmud; Farid.mahmud{at}sickkids.ca

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.

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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