Celiac Disease and Diabetes Longitudinal Follow-up and Evaluation Study

Diabetes Mellitus, Type 1 Clinical Trial

— CD-LiFE  

Official title:

Celiac Disease and Diabetes Longitudinal Follow-up and Evaluation Study (CD-LiFE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03122093
• Other study ID #: 1000053646
• Status: Completed
• Start date: May 1, 2017
• Est. completion date: January 31, 2021

Study information

• Verified date: March 2021
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Celiac
• Celiac Disease
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario
Canada	Kingston General Hospital	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

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Daily Gluten Intake	This outcome will be measured through interview/assessment data.	2 Years
Primary	Celiac Dietary Adherence	This outcome will be measured through the Celiac Dietary Adherence test (CDAT) questionnaire.	2 Years
Primary	TTG-IgA Serology	This outcome will be measured through TTG-IgA serology testing for inflammatory markers for celiac disease.	2 Years
Secondary	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
Secondary	Daily Activity Levels	This outcome will be measured through the self-reported Habitual Activity Estimation Scale (HAES).	2 Years
Secondary	Self-Perceived Wellness	This outcome will be measured through a self-reported Self-Perceived Wellness Scale.	2 Years
Secondary	Metabolic Control	This outcome will be measured through self-reports and lab-provided HbA1c values.	2 years
Secondary	Kidney Function	This outcome will be measured through lab-provided Albumin/Creatinine Ratios.	2 years
Secondary	Hypoglycemic episodes.	The frequency and severity of hypoglycemic episodes will be recorded at each clinic visit via self-report.	2 years
Secondary	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
Secondary	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