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To the investigators' knowledge, no single long-term prospective observational study has assessed dietary factors, diabetes clinical variables (metabolic control and associated complications), and self -perceived health and wellness in T1D patients (both pediatric and adult) with CD identified by screening (positive/weakly positive serology). The aim of the current study is to observe the short- and long-term outcomes for Type 1 diabetic patients with new serology positive asymptomatic CD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD-DIET Gluten-Free Diet Group | This former randomized control trial (RCT) group received a gluten-free education and continued support from a dietitian for a 1-year period via the CD-DIET Study (NCT01566110) | ||
| CD-DIET Gluten-Containing Diet Group | This former RCT group did not receive a gluten-free education and 1-year support from a dietitian via the CD-DIET Study (NCT01566110), but rather a single gluten-free education session upon exiting the study. | ||
| CD-DIET Ineligibles/Refusals | This group contains T1D/CD individuals who were not eligible or refused to join the CD-DIET RCT (e.g. already self-selected their diet or had no interest in being randomized). These individuals were instead redirected to the clinical route. |
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| Measure | Description | Time Frame |
|---|---|---|
| Average Daily Gluten Intake | This outcome will be measured through interview/assessment data. | 2 Years |
| Celiac Dietary Adherence | This outcome will be measured through the Celiac Dietary Adherence test (CDAT) questionnaire. | 2 Years |
| TTG-IgA Serology | This outcome will be measured through TTG-IgA serology testing for inflammatory markers for celiac disease. | 2 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Health-related Quality of Life | This outcome will be measured through the self-reported Quality of Life (PedsQL) Inventory Generic Core Scale (V.4.0) with Diabetes Module (V.3.0). | 2 Years |
| Daily Activity Levels |
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Inclusion Criteria:
Exclusion Criteria:
1. A condition which, in the opinion of the investigator, may interfere with the subject's ability to participate in the study.
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Patients with an established diagnosis of T1D and positive/weakly positive serologic CD after entering the screening portion of the CD-DIET study will be recruited to participate in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Farid Mahmud, MD | The Hospital for Sick Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster University | Hamilton | Ontario | Canada | |||
| Kingston General Hospital |
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| ID | Term |
|---|---|
| D002446 | Celiac Disease |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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This outcome will be measured through the self-reported Habitual Activity Estimation Scale (HAES).
| 2 Years |
| Self-Perceived Wellness | This outcome will be measured through a self-reported Self-Perceived Wellness Scale. | 2 Years |
| Metabolic Control | This outcome will be measured through self-reports and lab-provided HbA1c values. | 2 years |
| Kidney Function | This outcome will be measured through lab-provided Albumin/Creatinine Ratios. | 2 years |
| Hypoglycemic episodes. | The frequency and severity of hypoglycemic episodes will be recorded at each clinic visit via self-report. | 2 years |
| Presence of Type 1 Diabetes Complications | This outcome will be measured by monitoring the occurence of T1D health outcomes and complications over time through long-term medical record review follow-up. Complications include, but are not limited to: nephropathy, retinopathy, and cardiovascular disease in the study population. | 10 years |
| Presence of Celiac Disease Complications | This outcome will be measured by monitoring the occurence of celiac disease health outcomes and complications over time through long-term medical record review follow-up. Complications include, but are not limited to: osteoporosis and malnutrition in the study population. | 10 years |
| Kingston |
| Ontario |
| Canada |
| London Health Sciences | London | Ontario | Canada |
| St. Joseph's Healthcare | London | Ontario | Canada |
| The Ottawa Hospital | Ottawa | Ontario | Canada |
| The Hospital for Sick Children | Toronto | Ontario | M5V1X8 | Canada |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |