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

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

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 Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 1; Celiac Disease; Celiac

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada
      • McMaster University
    • Kingston, Ontario, Canada
      • Kingston General Hospital
    • London, Ontario, Canada
      • London Health Sciences
    • London, Ontario, Canada
      • St. Joseph's Healthcare
    • Ottawa, Ontario, Canada
      • The Ottawa Hospital
    • Toronto, Ontario, Canada, M5V1X8
      • The Hospital For Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Daily Gluten Intake	This outcome will be measured through interview/assessment data.	2 Years
Celiac Dietary Adherence	This outcome will be measured through the Celiac Dietary Adherence test (CDAT) questionnaire.	2 Years
TTG-IgA Serology	This outcome will be measured through TTG-IgA serology testing for inflammatory markers for celiac disease.	2 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related Quality of Life	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).	2 Years
Daily Activity Levels	This outcome will be measured through the self-reported Habitual Activity Estimation Scale (HAES).	2 Years
Self-Perceived Wellness	This outcome will be measured through a self-reported Self-Perceived Wellness Scale.	2 Years
Metabolic Control	This outcome will be measured through self-reports and lab-provided HbA1c values.	2 years
Kidney Function	This outcome will be measured through lab-provided Albumin/Creatinine Ratios.	2 years
Hypoglycemic episodes.	The frequency and severity of hypoglycemic episodes will be recorded at each clinic visit via self-report.	2 years
Presence of Type 1 Diabetes Complications	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.	10 years
Presence of Celiac Disease Complications	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.	10 years

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Investigators: Principal Investigator: Farid Mahmud, MD, The Hospital For Sick Children

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): January 31, 2021

Study Registration Dates

• First Submitted: April 3, 2017
• First Submitted That Met QC Criteria: April 17, 2017
• First Posted (Actual): April 20, 2017

Study Record Updates

• Last Update Posted (Actual): March 3, 2021
• Last Update Submitted That Met QC Criteria: March 2, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: pediatric; T1D; celiac disease; dietary treatment
• Additional Relevant MeSH Terms: Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Malabsorption Syndromes; Diabetes Mellitus; Diabetes Mellitus, Type 1; Celiac Disease
• Other Study ID Numbers: 1000053646

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No