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.
Study Goal
The researchers aimed to evaluate the efficacy and safety of a gluten-free diet (GFD) in patients with type 1 diabetes and asymptomatic celiac disease, focusing on its impact on glycated hemoglobin, bone mineral density, blood glucose variability, and quality of life.
Results Summary
The study is a randomized controlled trial comparing a GFD to a regular gluten-containing diet over one year, but the abstract does not provide specific results on outcomes. The findings are expected to offer high-quality evidence on the effects of GFD in this population.
Population
Children and adults (8-45 years) with type 1 diabetes and asymptomatic celiac disease.
Effective Dosage
Not specified
Duration
1 year
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
gluten-free diet (GFD) | neutral | change in glycated haemoglobin | patients with type 1 diabetes with asymptomatic CD | - | evaluate the impact | #1 |
gluten-free diet (GFD) | neutral | bone mineral density | GFD-treated and the regular diet group | - | evaluate changes | #2 |
gluten-free diet (GFD) | neutral | blood glucose variability | GFD-treated and the regular diet group | - | evaluate changes | #3 |
gluten-free diet (GFD) | neutral | health-related quality of life | GFD-treated and the regular diet group | - | evaluate changes | #4 |
GFD treatment | neutral | glycaemic control | asymptomatic children and adults with CD and type 1 diabetes | - | provide high-quality evidence as to the impact | #5 |
GFD treatment | neutral | complications | asymptomatic children and adults with CD and type 1 diabetes | - | provide high-quality evidence as to the impact | #6 |
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.