NCT01566110

Celiac Disease and Diabetes- Dietary Intervention and Evaluation Trial

A Randomized Controlled Trial to Evaluate the Efficacy and Safety of a Gluten-Free Diet in Patients With Asymptomatic Celiac Disease and Type 1 Diabetes, Celiac Disease and Diabetes - Dietary Intervention and Evaluation Trial (CD-DIET)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 8 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Currently no consensus exists on the optimal way to manage asymptomatic patients with celiac disease (CD) and Type 1 diabetes (T1D). The impact of dietary treatment as it pertains to clinically relevant outcomes such as metabolic control, bone mineralization and wellbeing will be evaluated in this study. A randomized controlled study longitudinally evaluating HbA1c and glycemic excursions using continuous glucose monitoring will rigorously determine the impact of a gluten-free diet (GFD) on blood glucose variability in patients with T1D.

Conditions

• Celiac Disease
• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Gluten Free Diet	Subjects assigned to the intervention group will receive a standardized dietary education intervention that will inform subjects and family members of the effects of gluten on the gastrointestinal tract and emphasize the need to adhere to a diet that is gluten-free. This intervention will be delivered by a dietician who is trained in celiac disease and gluten free diet.

Timeline

• Start date: 2012-03-01
• Primary completion: 2018-03-01
• Completion: 2018-03-01
• First posted: 2012-03-29
• Last updated: 2018-09-05

Locations

7 sites across 1 country: Canada