Celiac Disease, Diabetes Mellitus, Type 1
Conditions
Keywords
pediatric, dietary treatment, celiac disease, T1D
Brief 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.
Interventions
DIETARY_SUPPLEMENTGluten 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.
Sponsors
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
Subjects must meet each of the following criteria for inclusion into the study: 1. Males and females age between 8 and 45 years. 2. Diagnosis of T1D by American Diabetes Association (ADA) criteria with duration of T1D greater than 1 year. 3. CD screen positive (Positive TTG serology). 4. Presence of a positive duodenal biopsy for CD (Marsh score of 2 or greater). 5. Ability of the subject or a legally authorized representative to speak and read English or French. 6. Ability of the subject to participate in all aspects of this clinical trial. 7. Written informed consent must be obtained and documented, with assent of the child if \<14 years of age.
Exclusion criteria
1. Prior diagnosis of CD. 2. Symptoms or other evidence of overt CD defined by at least one of: * CD symptoms using the Gastrointestinal Symptom Scale \[GISS\] * Impaired growth * Anemia 3. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Metabolic Control | Change from Baseline over 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hypoglycemic Episodes | Frequency over 12 months | 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. |
| Continuous Glucose Monitoring | Baseline, 6 months and 12 months after randomization | 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. |
Countries
Canada
Outcome results
None listed