Celiac, Celiac Disease, Diabetes Mellitus, Type 1
Conditions
Keywords
pediatric, dietary treatment, celiac disease, T1D
Brief summary
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.
Interventions
None listed
Sponsors
The Hospital for Sick Children
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
8 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Males and females between the ages of 8 and 50 years with positive/weakly positive serologic CD screening or who have completed the CD-DIET trial. 2. Diagnosis of T1D by American Diabetes Association (ADA) criteria with duration of T1D equal to or greater than 1 year from time of signing Screening Informed Consent for CD-DIET trial. 3. Ability of the subject or a legally authorized representative to speak and read English or French. 4. Participation in the screening portion of the CD-DIET Study.
Exclusion criteria
1\. A condition which, in the opinion of the investigator, may interfere with the subject's ability to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Daily Gluten Intake | 2 Years | This outcome will be measured through interview/assessment data. |
| Celiac Dietary Adherence | 2 Years | This outcome will be measured through the Celiac Dietary Adherence test (CDAT) questionnaire. |
| TTG-IgA Serology | 2 Years | This outcome will be measured through TTG-IgA serology testing for inflammatory markers for celiac disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Metabolic Control | 2 years | This outcome will be measured through self-reports and lab-provided HbA1c values. |
| Kidney Function | 2 years | This outcome will be measured through lab-provided Albumin/Creatinine Ratios. |
| Health-related Quality of Life | 2 Years | 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). |
| Presence of Type 1 Diabetes Complications | 10 years | 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. |
| Presence of Celiac Disease Complications | 10 years | 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. |
| Hypoglycemic episodes. | 2 years | The frequency and severity of hypoglycemic episodes will be recorded at each clinic visit via self-report. |
| Daily Activity Levels | 2 Years | This outcome will be measured through the self-reported Habitual Activity Estimation Scale (HAES). |
| Self-Perceived Wellness | 2 Years | This outcome will be measured through a self-reported Self-Perceived Wellness Scale. |
Countries
Canada
Outcome results
None listed