Celiac Disease and Diabetes Longitudinal Follow-up and Evaluation Study

NCT ID: NCT03122093

Last Updated: 2021-03-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2021-01-31

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.

Conditions

Celiac Disease; Celiac; Diabetes Mellitus, Type 1

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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)

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Farid Mahmud

Principal Investigator, Staff Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Farid Mahmud, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

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, Canada

Countries

Canada

Other Identifiers

1000053646

Identifier Type: -

Identifier Source: org_study_id