Celiac DiseaseCD-LiFENCT03122093
Celiac Disease and Diabetes Longitudinal Follow-up and Evaluation Study
An observational study of Celiac Disease and Celiac, run by The Hospital for Sick Children at 6 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 50 years
- Conditions the study is for
- Celiac Disease, Celiac, Diabetes Mellitus, Type 1
- How many people
- 90 participants
- Where
- 6 sitesCanada
- Study dates
- 1 May 2017to 31 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 1. A condition which, in the opinion of the investigator, may interfere with the subject's ability to participate in the study.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
McMaster University
Hamilton, Ontario
Kingston General Hospital
Kingston, Ontario
London Health Sciences
London, Ontario
St. Joseph's Healthcare
London, Ontario
The Ottawa Hospital
Ottawa, Ontario
The Hospital for Sick Children
Toronto, Ontario, M5V1X8
About this study
Official title: 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.
- Conditions
- Celiac Disease, Celiac, Diabetes Mellitus, Type 1
- Keywords
- pediatric, dietary treatment, celiac disease, T1D
- Medical subject headings
- Celiac Disease, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Average Daily Gluten Intake
This outcome will be measured through interview/assessment data.
Measured: 2 Years
Celiac Dietary Adherence
This outcome will be measured through the Celiac Dietary Adherence test (CDAT) questionnaire.
Measured: 2 Years
TTG-IgA Serology
This outcome will be measured through TTG-IgA serology testing for inflammatory markers for celiac disease.
Measured: 2 Years
Secondary outcomes (8)
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).
Measured: 2 Years
Daily Activity Levels
This outcome will be measured through the self-reported Habitual Activity Estimation Scale (HAES).
Measured: 2 Years
Self-Perceived Wellness
This outcome will be measured through a self-reported Self-Perceived Wellness Scale.
Measured: 2 Years
Metabolic Control
This outcome will be measured through self-reports and lab-provided HbA1c values.
Measured: 2 years
Kidney Function
This outcome will be measured through lab-provided Albumin/Creatinine Ratios.
Measured: 2 years
Hypoglycemic episodes.
The frequency and severity of hypoglycemic episodes will be recorded at each clinic visit via self-report.
Measured: 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.
Measured: 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.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2017
- Study start1 May 2017
- Primary completion31 Dec 2020
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farid Mahmud, The Hospital for Sick Children
- Investigators
- Farid Mahmud, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03122093
- Sponsor's protocol ID
- 1000053646
- Acronym
- CD-LiFE
- Status last verified
- Mar 2021
- First submitted
- 3 Apr 2017
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Celiac Disease and Diabetes Longitudinal Follow-up and Evaluation Study (CD-LiFE)
- ClinicalTrials.gov ID
- NCT03122093
- Acronym / sponsor ID
- CD-LiFE / 1000053646
- Conditions
- Celiac Disease, Celiac, Diabetes Mellitus, Type 1
- Keywords
- pediatric, dietary treatment, celiac disease, T1D
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 20 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 8 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 1. A condition which, in the opinion of the investigator, may interfere with the subject's ability to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
8 secondary outcomes
Health-related Quality of Life
Time frame: 2 Years
Daily Activity Levels
Time frame: 2 Years
Self-Perceived Wellness
Time frame: 2 Years
Metabolic Control
Time frame: 2 years
Kidney Function
Time frame: 2 years
Hypoglycemic episodes.
Time frame: 2 years
Presence of Type 1 Diabetes Complications
Time frame: 10 years
Presence of Celiac Disease Complications
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Farid Mahmud, MD principal investigator
The Hospital for Sick Children
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Celiac Disease and Celiac, run by The Hospital for Sick Children at 6 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Daily Gluten Intake (time frame: 2 Years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.