Celiac Disease and Diabetes Longitudinal Follow-up and Evaluation Study (CD-LiFE)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 90
- Locations
- 6
- Primary Endpoint
- Average Daily Gluten Intake
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 8 Years to 50 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Average Daily Gluten Intake
Time Frame: 2 Years
This outcome will be measured through interview/assessment data.
Celiac Dietary Adherence
Time Frame: 2 Years
This outcome will be measured through the Celiac Dietary Adherence test (CDAT) questionnaire.
TTG-IgA Serology
Time Frame: 2 Years
This outcome will be measured through TTG-IgA serology testing for inflammatory markers for celiac disease.
Secondary Outcomes
- Daily Activity Levels(2 Years)
- Metabolic Control(2 years)
- Presence of Type 1 Diabetes Complications(10 years)
- Kidney Function(2 years)
- Hypoglycemic episodes.(2 years)
- Presence of Celiac Disease Complications(10 years)
- Health-related Quality of Life(2 Years)
- Self-Perceived Wellness(2 Years)
Investigators
Farid Mahmud
Principal Investigator, Staff Physician
The Hospital for Sick Children