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NCT Number: NCT03122093

Celiac Disease and Diabetes Longitudinal Follow-up and Evaluation Study

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.

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Key information

Conditions

Celiac Disease Autoimmune Diseases Celiac Diabetes Mellitus Diabetes Mellitus, Type 1 Digestive System Diseases Endocrine System Diseases Gastrointestinal Diseases Glucose Metabolism Disorders Immune System Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases

Age range

8 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

McMaster University, Hamilton, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Average Daily Gluten Intake

    Time frame: 2 Years

    This outcome will be measured through interview/assessment data.

  2. Celiac Dietary Adherence

    Time frame: 2 Years

    This outcome will be measured through the Celiac Dietary Adherence test (CDAT) questionnaire.

  3. 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

  1. Health-related Quality of Life

    Time frame: 2 Years

    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. Daily Activity Levels

    Time frame: 2 Years

    This outcome will be measured through the self-reported Habitual Activity Estimation Scale (HAES).

  3. Self-Perceived Wellness

    Time frame: 2 Years

    This outcome will be measured through a self-reported Self-Perceived Wellness Scale.

  4. Metabolic Control

    Time frame: 2 years

    This outcome will be measured through self-reports and lab-provided HbA1c values.

  5. Kidney Function

    Time frame: 2 years

    This outcome will be measured through lab-provided Albumin/Creatinine Ratios.

  6. Hypoglycemic episodes.

    Time frame: 2 years

    The frequency and severity of hypoglycemic episodes will be recorded at each clinic visit via self-report.

  7. Presence of Type 1 Diabetes Complications

    Time frame: 10 years

    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.

  8. Presence of Celiac Disease Complications

    Time frame: 10 years

    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.

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

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

Acronym: CD-LiFE

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Apr 20, 2017
Registry last updated
Mar 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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