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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diet Intervention Group | Experimental |
| |
| Control Group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gluten Free Diet | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Hypoglycemic Episodes | The frequency and severity of hypoglycemic episodes will be recorded at each clinic visit. These will be classified as severe hypoglycemic episodes in subjects with normal hypoglycemic awareness. | Frequency over 12 months |
| Continuous Glucose Monitoring |
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Inclusion Criteria:
Subjects must meet each of the following criteria for inclusion into the study:
Exclusion Criteria:
Prior diagnosis of CD.
Symptoms or other evidence of overt CD defined by at least one of:
Presence of recurrent apthous ulcers (painful mouth ulcers involving mucous membranes) or dermatitis herpetiformis (blistering skin rash). Mouth or skin lesions known to be related to diagnosed herpes are not included in this exclusion criteria.
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.
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| Name | Affiliation | Role |
|---|---|---|
| Farid Mahmud, MD | The Hospital for Sick Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster University | Hamilton | Ontario | Canada | |||
| Kingston General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35176765 | Derived | 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. | |
| 33852450 | Derived |
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| ID | Term |
|---|---|
| D002446 | Celiac Disease |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D055050 | Diet, Gluten-Free |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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|
Data will be evaluated for data quality, overall mean glucose, overall variability of blood glucose, patterns of blood glucose excursion, and measures of quality of glycemic control. |
| Baseline, 6 months and 12 months after randomization |
| 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 |
| 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. |
| 33524131 | Derived | 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. |
| 32345653 | Derived | 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. |
| 26692164 | Derived | 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. |
| 25968008 | Derived | 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. |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |