Celiac Disease and Diabetes- Dietary Intervention and Evaluation Trial
CD-DIET
A Randomized Controlled Trial to Evaluate the Efficacy and Safety of a Gluten-Free Diet in Patients With Asymptomatic Celiac Disease and Type 1 Diabetes, Celiac Disease and Diabetes - Dietary Intervention and Evaluation Trial (CD-DIET)
1 other identifier
interventional
50
1 country
7
Brief Summary
Currently no consensus exists on the optimal way to manage asymptomatic patients with celiac disease (CD) and Type 1 diabetes (T1D). The impact of dietary treatment as it pertains to clinically relevant outcomes such as metabolic control, bone mineralization and wellbeing will be evaluated in this study. A randomized controlled study longitudinally evaluating HbA1c and glycemic excursions using continuous glucose monitoring will rigorously determine the impact of a gluten-free diet (GFD) on blood glucose variability in patients with T1D.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2012
Longer than P75 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 27, 2012
CompletedFirst Posted
Study publicly available on registry
March 29, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedSeptember 5, 2018
September 1, 2018
6 years
March 27, 2012
September 4, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Metabolic Control
As a standard measure of diabetes control, HbA1c is assessed on a frequent and regular basis as recommended by the CDA 2008 guidelines in both pediatric and adult patients. HbA1c is synthesized throughout the cycle of a red blood cell and reflects the degree of chronic hyperglycemia present in patients with diabetes.
Change from Baseline over 1 year
Secondary Outcomes (2)
Hypoglycemic Episodes
Frequency over 12 months
Continuous Glucose Monitoring
Baseline, 6 months and 12 months after randomization
Study Arms (2)
Diet Intervention Group
EXPERIMENTALControl Group
NO INTERVENTIONSubjects assigned to the control group will continue their usual diet. They will receive dietary teaching at each study visit as part of their diabetes management.
Interventions
Subjects assigned to the intervention group will receive a standardized dietary education intervention that will inform subjects and family members of the effects of gluten on the gastrointestinal tract and emphasize the need to adhere to a diet that is gluten-free. This intervention will be delivered by a dietician who is trained in celiac disease and gluten free diet.
Eligibility Criteria
You may qualify if:
- Males and females age between 8 and 45 years.
- Diagnosis of T1D by American Diabetes Association (ADA) criteria with duration of T1D greater than 1 year.
- CD screen positive (Positive TTG serology).
- Presence of a positive duodenal biopsy for CD (Marsh score of 2 or greater).
- Ability of the subject or a legally authorized representative to speak and read English or French.
- Ability of the subject to participate in all aspects of this clinical trial.
- Written informed consent must be obtained and documented, with assent of the child if \<14 years of age.
You may not qualify if:
- Prior diagnosis of CD.
- Symptoms or other evidence of overt CD defined by at least one of:
- CD symptoms using the Gastrointestinal Symptom Scale \[GISS\]
- Impaired growth
- Anemia
- Conditions which in the opinion of the investigator may interfere with the subject's ability to participate in the study.
- Prior enrolment in the current study.
- Concurrent enrolment in a longitudinal intervention study.
- Previously diagnosed or treated osteoporosis.
- Pregnancy or lactation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
McMaster University
Hamilton, Ontario, Canada
Kingston General Hospital
Kingston, Ontario, Canada
London Health Sciences
London, Ontario, Canada
St. Joseph's Healthcare
London, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
The Hospital for Sick Children
Toronto, Ontario, M5V1X8, Canada
LMC Diabetes and Endocrinology
Toronto, Ontario, Canada
Related Publications (6)
De Melo EN, Clarke ABM, McDonald C, Saibil F, Lochnan HA, Punthakee Z, Assor E, Marcon MA, Mahmud FH. Gastrointestinal Symptoms in Type 1 Diabetes: Relationship With Autoimmune and Microvascular Complications. J Clin Endocrinol Metab. 2022 May 17;107(6):e2431-e2437. doi: 10.1210/clinem/dgac093.
PMID: 35176765DERIVEDGould MJ, Mahmud FH, Clarke ABM, McDonald C, Saibil F, Punthakee Z, Marcon MA. Accuracy of Screening Tests for Celiac Disease in Asymptomatic Patients With Type 1 Diabetes. Am J Gastroenterol. 2021 Jul 1;116(7):1545-1549. doi: 10.14309/ajg.0000000000001193.
PMID: 33852450DERIVEDWeiman DI, Mahmud FH, Clarke ABM, Assor E, McDonald C, Saibil F, Lochnan HA, Punthakee Z, Marcon MA; CD-DIET Study Group. Impact of a Gluten-Free Diet on Quality of Life and Health Perception in Patients With Type 1 Diabetes and Asymptomatic Celiac Disease. J Clin Endocrinol Metab. 2021 Apr 23;106(5):e1984-e1992. doi: 10.1210/clinem/dgaa977.
PMID: 33524131DERIVEDMahmud FH, Clarke ABM, Joachim KC, Assor E, McDonald C, Saibil F, Lochnan HA, Punthakee Z, Parikh A, Advani A, Shah BR, Perkins BA, Zuijdwijk CS, Mack DR, Koltin D, De Melo EN, Hsieh E, Mukerji G, Gilbert J, Bax K, Lawson ML, Cino M, Beaton MD, Saloojee NA, Lou O, Gallego PH, Bercik P, Houlden RL, Aronson R, Kirsch SE, Paterson WG, Marcon MA. Screening and Treatment Outcomes in Adults and Children With Type 1 Diabetes and Asymptomatic Celiac Disease: The CD-DIET Study. Diabetes Care. 2020 Jul;43(7):1553-1556. doi: 10.2337/dc19-1944. Epub 2020 Apr 28.
PMID: 32345653DERIVEDAssor E, Marcon MA, Hamilton N, Fry M, Cooper T, Mahmud FH. Design of a dietary intervention to assess the impact of a gluten-free diet in a population with type 1 Diabetes and Celiac Disease. BMC Gastroenterol. 2015 Dec 21;15:181. doi: 10.1186/s12876-015-0413-0.
PMID: 26692164DERIVEDMahmud FH, De Melo EN, Noordin K, Assor E, Sahota K, Davies-Shaw J, Cutz E, Somers G, Lawson M, Mack DR, Gallego P, McDonald C, Beaton MD, Bax K, Saibil F, Gilbert J, Kirsch S, Perkins BA, Cino M, Szentgyorgyi E, Koltin D, Parikh A, Mukerji G, Advani A, Lou O, Marcon MA. The Celiac Disease and Diabetes-Dietary Intervention and Evaluation Trial (CD-DIET) protocol: a randomised controlled study to evaluate treatment of asymptomatic coeliac disease in type 1 diabetes. BMJ Open. 2015 May 11;5(5):e008097. doi: 10.1136/bmjopen-2015-008097.
PMID: 25968008DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Farid Mahmud, MD
The Hospital for Sick Children
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Staff Physician
Study Record Dates
First Submitted
March 27, 2012
First Posted
March 29, 2012
Study Start
March 1, 2012
Primary Completion
March 1, 2018
Study Completion
March 1, 2018
Last Updated
September 5, 2018
Record last verified: 2018-09