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.
abstract: BACKGROUND
  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
  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.
  
  
  BACKGROUND
  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.
  
  
  BACKGROUND
  NCT01566110.
authors.affiliation: Department of Pediatrics, Division of Endocrinology, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Farid H
authors.initials: FH
authors.lastname: Mahmud
authors.affiliation: Department of Pediatrics, Division of Endocrinology, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Emilia N
authors.initials: EN
authors.lastname: De Melo
authors.affiliation: Department of Pediatrics, Division of Endocrinology, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Karima
authors.initials: K
authors.lastname: Noordin
authors.affiliation: Department of Pediatrics, Division of Endocrinology, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Esther
authors.initials: E
authors.lastname: Assor
authors.affiliation: Department of Pediatrics, Division of Endocrinology, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Kamaljeet
authors.initials: K
authors.lastname: Sahota
authors.affiliation: Department of Pediatrics, Division of Endocrinology, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Jolie
authors.initials: J
authors.lastname: Davies-Shaw
authors.affiliation: Department of Pathology, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Ernest
authors.initials: E
authors.lastname: Cutz
authors.affiliation: Department of Pathology, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Gino
authors.initials: G
authors.lastname: Somers
authors.affiliation: Division of Endocrinology and Metabolism, Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada.
authors.forename: Margaret
authors.initials: M
authors.lastname: Lawson
authors.affiliation: Division of Gastroenterology, Hepatology and Nutrition, Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada.
authors.forename: David R
authors.initials: DR
authors.lastname: Mack
authors.affiliation: Division of Endocrinology Paediatrics, London Health Sciences Centre, London, Ontario, Canada.
authors.forename: Patricia
authors.initials: P
authors.lastname: Gallego
authors.affiliation: Division of Endocrinology and Metabolism, St. Joseph Health Care, London Health Sciences Centre, London, Ontario, Canada.
authors.forename: Charlotte
authors.initials: C
authors.lastname: McDonald
authors.affiliation: Division of Gastroenterology, London Health Sciences Centre, London, Ontario, Canada.
authors.forename: Melanie D
authors.initials: MD
authors.lastname: Beaton
authors.affiliation: Pediatric Gastroenterology, Department of Pediatrics, Children's Hospital, London Health Sciences Centre, London, Ontario, Canada.
authors.forename: Kevin
authors.initials: K
authors.lastname: Bax
authors.affiliation: Division of Gastroenterology, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.
authors.forename: Fred
authors.initials: F
authors.lastname: Saibil
authors.affiliation: Division of Endocrinology and Metabolism, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.
authors.forename: Jeremy
authors.initials: J
authors.lastname: Gilbert
authors.affiliation: Division of Endocrinology, Markham Stouffville Hospital, Toronto, Ontario, Canada.
authors.forename: Susan
authors.initials: S
authors.lastname: Kirsch
authors.affiliation: Division of Endocrinology and Metabolism, Department of Medicine, University Health Network, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Bruce A
authors.initials: BA
authors.lastname: Perkins
authors.affiliation: Division of Gastroenterology, Toronto Western Hospital, University Health Network, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Maria
authors.initials: M
authors.lastname: Cino
authors.affiliation: Department of Pathology, University Health Network, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Eva
authors.initials: E
authors.lastname: Szentgyorgyi
authors.affiliation: Division of Endocrinology, Trillium Health Partners, Mississauga, Ontario, Canada.
authors.forename: Dror
authors.initials: D
authors.lastname: Koltin
authors.affiliation: Division of Endocrinology, Trillium Health Partners, Mississauga, Ontario, Canada.
authors.forename: Amish
authors.initials: A
authors.lastname: Parikh
authors.affiliation: Division of Endocrinology, Women's College Hospital, Toronto, Ontario, Canada.
authors.forename: Geetha
authors.initials: G
authors.lastname: Mukerji
authors.affiliation: Division of Endocrinology, St. Michael's Hospital, Toronto, Ontario, Canada.
authors.forename: Andrew
authors.initials: A
authors.lastname: Advani
authors.affiliation: Juvenile Diabetes Research Foundation-Canadian Clinical Trials Network (JDRF-CCTN), Toronto, Ontario, Canada.
authors.forename: Olivia
authors.initials: O
authors.lastname: Lou
authors.affiliation: Division of Gastroenterology, Hepatology and Nutrition, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Margaret A
authors.initials: MA
authors.lastname: Marcon
mesh_terms: D000293:Adolescent; D000328:Adult; D001786:Blood Glucose / Q000378:metabolism*; D002446:Celiac Disease / Q000150:complications* / Q000178:diet therapy; D002648:Child; D002985:Clinical Protocols; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000150:complications* / Q000178:diet therapy; D055050:Diet, Gluten-Free; D005247:Feeding Behavior; D005260:Female; D005983:Glutens / Q000009:adverse effects; D006442:Glycated Hemoglobin / Q000378:metabolism*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009864:Ontario; D011788:Quality of Life; D012107:Research Design; D055815:Young Adult
chemical_list: D001786:Blood Glucose; D005983:Glutens; D006442:Glycated Hemoglobin