Clinical trial NCT03122093: Celiac Disease and Diabetes Longitudinal Follow-up and Evaluation Study
Official title: Celiac Disease and Diabetes Longitudinal Follow-up and Evaluation Study (CD-LiFE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Celiac Disease
Celiac
Diabetes Mellitus, Type 1
Keywords: pediatric
dietary treatment
celiac disease
T1D
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2017-04-20
Enrollment: 90
Sex: ALL
Minimum age (years): 8
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with an established diagnosis of T1D and positive/weakly positive serologic CD after entering the screening portion of the CD-DIET study will be recruited to participate in this study.

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.


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.

Primary outcomes:
measure: Average Daily Gluten Intake
timeFrame: 2 Years
measure: Celiac Dietary Adherence
timeFrame: 2 Years
measure: TTG-IgA Serology
timeFrame: 2 Years
Secondary outcomes:
measure: Health-related Quality of Life
timeFrame: 2 Years
measure: Daily Activity Levels
timeFrame: 2 Years
measure: Self-Perceived Wellness
timeFrame: 2 Years
measure: Metabolic Control
timeFrame: 2 years
measure: Kidney Function
timeFrame: 2 years
measure: Hypoglycemic episodes.
timeFrame: 2 years
measure: Presence of Type 1 Diabetes Complications
timeFrame: 10 years
measure: Presence of Celiac Disease Complications
timeFrame: 10 years
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences
state: Ontario
city: London
country: Canada
facility: St. Joseph's Healthcare
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Farid Mahmud, MD
role: PRINCIPAL_INVESTIGATOR
References: