Celiac Disease and Diabetes- Dietary Intervention and Evaluation Trial

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Celiac Disease, Diabetes Mellitus, Type 1

Intervention / Treatment
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* Dietary Supplement: Gluten Free Diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must meet each of the following criteria for inclusion into the study: Males and females age between 8 and 45 years. Diagnosis of T1D by American Diabetes Association (ADA) criteria with duration of T1D greater than 1 year. CD screen positive (Positive TTG serology). Presence of a positive duodenal biopsy for CD (Marsh score of 2 or greater). Ability of the subject or a legally authorized representative to speak and read English or French. Ability of the subject to participate in all aspects of this clinical trial. Written informed consent must be obtained and documented, with assent of the child if <14 years of age. Exclusion Criteria: Prior diagnosis of CD. Symptoms or other evidence of overt CD defined by at least one of: CD symptoms using the Gastrointestinal Symptom Scale [GISS] Impaired growth Anemia Presence of recurrent apthous ulcers (painful mouth ulcers involving mucous membranes) or dermatitis herpetiformis (blistering skin rash). Mouth or skin lesions known to be related to diagnosed herpes are not included in this exclusion criteria. Conditions which in the opinion of the investigator may interfere with the subject's ability to participate in the study. Prior enrolment in the current study. Concurrent enrolment in a longitudinal intervention study. Previously diagnosed or treated osteoporosis. Pregnancy or lactation.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diet Intervention Group<br> | Dietary Supplement: Gluten Free Diet<br>* 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.<br>|
| No Intervention: Control Group<br>Subjects assigned to the control group will continue their usual diet. They will receive dietary teaching at each study visit as part of their diabetes management. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic Control | As a standard measure of diabetes control, HbA1c is assessed on a frequent and regular basis as recommended by the CDA 2008 guidelines in both pediatric and adult patients. HbA1c is synthesized throughout the cycle of a red blood cell and reflects the degree of chronic hyperglycemia present in patients with diabetes. | Change from Baseline over 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoglycemic Episodes | The frequency and severity of hypoglycemic episodes will be recorded at each clinic visit. These will be classified as severe hypoglycemic episodes in subjects with normal hypoglycemic awareness. | Frequency over 12 months | 
| Continuous Glucose Monitoring | Data will be evaluated for data quality, overall mean glucose, overall variability of blood glucose, patterns of blood glucose excursion, and measures of quality of glycemic control. | Baseline, 6 months and 12 months after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric, dietary treatment, celiac disease, T1D