Celiac Disease and Diabetes- Dietary Intervention and Evaluation Trial (CD-DIET)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01566110|
Recruitment Status : Active, not recruiting
First Posted : March 29, 2012
Last Update Posted : April 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Celiac Disease Diabetes Mellitus, Type 1||Dietary Supplement: Gluten Free Diet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Study Start Date :||March 2012|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
|Experimental: Diet Intervention Group||
Dietary Supplement: 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.
No Intervention: 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.
- Metabolic Control [ Time Frame: Change from Baseline over 1 year ]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.
- Hypoglycemic Episodes [ Time Frame: Frequency over 12 months ]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.
- Continuous Glucose Monitoring [ Time Frame: Baseline, 6 months and 12 months after randomization ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01566110
|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, M5V1X8|
|LMC Diabetes and Endocrinology|
|Toronto, Ontario, Canada|
|Principal Investigator:||Farid Mahmud, MD||The Hospital for Sick Children|