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

The Hospital for Sick Children

Status: Completed

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

Study type: Observational

Funder types: Other

Identifiers

NCT03122093

1000053646

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 8 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

90 participants in 3 patient groups

CD-DIET Gluten-Free Diet Group

Description:

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

Description:

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

Description:

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.