Celiac Disease and Diabetes- Dietary Intervention and Evaluation Trial
NCT ID: NCT01566110
Last Updated: 2018-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2012-03-31
2018-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Diet Intervention Group
Gluten Free Diet
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.
Control Group
Subjects 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.
No interventions assigned to this group
Interventions
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Gluten Free Diet
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
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Inclusion Criteria
1. Males and females age between 8 and 45 years.
2. Diagnosis of T1D by American Diabetes Association (ADA) criteria with duration of T1D greater than 1 year.
3. CD screen positive (Positive TTG serology).
4. Presence of a positive duodenal biopsy for CD (Marsh score of 2 or greater).
5. Ability of the subject or a legally authorized representative to speak and read English or French.
6. Ability of the subject to participate in all aspects of this clinical trial.
7. Written informed consent must be obtained and documented, with assent of the child if \<14 years of age.
Exclusion Criteria
2. Symptoms or other evidence of overt CD defined by at least one of:
* CD symptoms using the Gastrointestinal Symptom Scale \[GISS\]
* Impaired growth
* Anemia
4. Conditions which in the opinion of the investigator may interfere with the subject's ability to participate in the study.
5. Prior enrolment in the current study.
6. Concurrent enrolment in a longitudinal intervention study.
7. Previously diagnosed or treated osteoporosis.
8. Pregnancy or lactation.
8 Years
45 Years
ALL
No
Sponsors
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The Hospital for Sick Children
OTHER
Responsible Party
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Farid Mahmud
Staff Physician
Principal Investigators
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Farid Mahmud, MD
Role: PRINCIPAL_INVESTIGATOR
The Hospital for Sick Children
Locations
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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, Canada
LMC Diabetes and Endocrinology
Toronto, Ontario, Canada
Countries
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References
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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.
Gould 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.
Weiman 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.
Mahmud 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.
Assor 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.
Mahmud 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.
Other Identifiers
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1000030346
Identifier Type: -
Identifier Source: org_study_id
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