Celiac Disease and Diabetes Longitudinal Follow-up and Evaluation Study

NCT03122093 | Completed

• 1 other identifier: 1000053646
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 6

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

Keywords

pediatric; dietary treatment; celiac disease; T1D

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Health-related Quality of Life

  2 Years

• Daily Activity Levels

  2 Years

• Self-Perceived Wellness

  2 Years

• Metabolic Control

  2 years

• Kidney Function

  2 years

Study Arms (3)

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.

Eligibility Criteria

• Age: 8 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• \. A condition which, in the opinion of the investigator, may interfere with the subject's ability to participate in the study.

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (6)

McMaster University

Hamilton, Ontario, Canada

Location

Kingston General Hospital

Kingston, Ontario, Canada

Location

London Health Sciences

London, Ontario, Canada

Location

St. Joseph's Healthcare

London, Ontario, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5V1X8, Canada

Location

MeSH Terms

Conditions

Celiac Disease; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Farid Mahmud, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Staff Physician

Study Record Dates

• First Submitted: April 3, 2017
• First Posted: April 20, 2017
• Study Start: May 1, 2017
• Primary Completion: December 31, 2020
• Study Completion: January 31, 2021
• Last Updated: March 3, 2021

Record last verified: 2021-03

Locations

CA (6)