Celiac Disease and Diabetes Longitudinal Follow-up and Evaluation Study

Completed

• Conditions: Diabetes Mellitus, Type 1; Celiac; Celiac Disease

• Registration Number: NCT03122093
• Lead Sponsor: The Hospital for Sick Children

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-03
• Study First Submitted QC: 2017-04-17
• Study First Posted: 2017-04-20
• Study Start: 2017-05-01
• Primary Completion: 2020-12-31
• Study Completion: 2021-01-31
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-02
• Last Update Posted: 2021-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Daily Activity Levels	2 Years	This outcome will be measured through the self-reported Habitual Activity Estimation Scale (HAES).
Metabolic Control	2 years	This outcome will be measured through self-reports and lab-provided HbA1c values.
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.
Hypoglycemic episodes.	2 years	The frequency and severity of hypoglycemic episodes will be recorded at each clinic visit via self-report.
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.
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).
Self-Perceived Wellness	2 Years	This outcome will be measured through a self-reported Self-Perceived Wellness Scale.

Trial Locations

Locations (6)

Kingston General Hospital; 🇨🇦 Kingston, Ontario, Canada

London Health Sciences; 🇨🇦 London, Ontario, Canada

St. Joseph's Healthcare; 🇨🇦 London, Ontario, Canada

McMaster University; 🇨🇦 Hamilton, Ontario, Canada

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada