Celiac Disease and Diabetes Longitudinal Follow-up and Evaluation Study

Study Purpose

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.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Observational
Eligible Ages 8 Years - 50 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03122093

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
The Hospital for Sick Children

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Farid Mahmud, MD
Principal Investigator Affiliation The Hospital for Sick Children

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Other
Overall Status Recruiting
Countries Canada

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Celiac Disease, Celiac, Diabetes Mellitus, Type 1

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

McMaster University, Hamilton, Ontario, Canada

Status

Not yet recruiting

Address

McMaster University

Hamilton, Ontario,

Site Contact

Ada Smith

905-525-9140 #22205

Kingston General Hospital, Kingston, Ontario, Canada

Status

Not yet recruiting

Address

Kingston General Hospital

Kingston, Ontario,

Site Contact

Adriana Breen

613-549-6666 #4927

London Health Sciences, London, Ontario, Canada

Status

Not yet recruiting

Address

London Health Sciences

London, Ontario,

Site Contact

Marge Lovell

marg.lovell@lhsc.on.ca

519-685-8500 #77548

St. Joseph's Healthcare, London, Ontario, Canada

Status

Not yet recruiting

Address

St. Joseph's Healthcare

London, Ontario,

Site Contact

Charlotte McDonald, MD

charlotte.mcdonald@sjhc.london.on.ca

519-646-6170

The Ottawa Hospital, Ottawa, Ontario, Canada

Status

Not yet recruiting

Address

The Ottawa Hospital

Ottawa, Ontario,

Site Contact

Denise Decurtis

613-738-8400 #81961

The Hospital for Sick Children, Toronto, Ontario, Canada

Status

Recruiting

Address

The Hospital for Sick Children

Toronto, Ontario, M5V1X8

Site Contact

416-813-6218

The content provided by the Celiac Disease Foundation on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. For a full description of terms please refer to: Privacy Policy and Terms of Use.