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

Sponsor

The Hospital for Sick Children (Other)

Overall Status

Completed

CT.gov ID

NCT03122093

Collaborator

(none)

Enrollment

Locations

Actual Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Celiac Disease Celiac Diabetes Mellitus, Type 1

Study Design

Study Type:

Observational

Actual Enrollment :

90 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 1, 2017

Actual Primary Completion Date :

Dec 31, 2020

Actual Study Completion Date :

Jan 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

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

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).
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.
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.
Hypoglycemic episodes. [2 years]
The frequency and severity of hypoglycemic episodes will be recorded at each clinic visit via self-report.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.
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.
Ability of the subject or a legally authorized representative to speak and read English or French.
Participation in the screening portion of the CD-DIET Study.

Exclusion Criteria:

A condition which, in the opinion of the investigator, may interfere with the subject's ability to participate in the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	McMaster University	Hamilton	Ontario	Canada
2	Kingston General Hospital	Kingston	Ontario	Canada
3	London Health Sciences	London	Ontario	Canada
4	St. Joseph's Healthcare	London	Ontario	Canada
5	The Ottawa Hospital	Ottawa	Ontario	Canada
6	The Hospital for Sick Children	Toronto	Ontario	Canada	M5V1X8