Celiac Disease and Diabetes- Dietary Intervention and Evaluation Trial (CD-DIET)
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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 :
Completed
First Posted : March 29, 2012
Last Update Posted : September 5, 2018
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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 |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Primary Completion Date : | March 2018 |
Actual Study Completion Date : | March 2018 |

Arm | Intervention/treatment |
---|---|
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.
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- 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.

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Ages Eligible for Study: | 8 Years to 45 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects must meet each of the following criteria for inclusion into the study:
- 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.
Exclusion Criteria:
- Prior diagnosis of CD.
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Symptoms or other evidence of overt CD defined by at least one of:
- CD symptoms using the Gastrointestinal Symptom Scale [GISS]
- Impaired growth
- Anemia
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01566110
Canada, Ontario | |
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, M5V1X8 | |
LMC Diabetes and Endocrinology | |
Toronto, Ontario, Canada |
Principal Investigator: | Farid Mahmud, MD | The Hospital for Sick Children |
Responsible Party: | Farid Mahmud, Staff Physician, The Hospital for Sick Children |
ClinicalTrials.gov Identifier: | NCT01566110 |
Other Study ID Numbers: |
1000030346 |
First Posted: | March 29, 2012 Key Record Dates |
Last Update Posted: | September 5, 2018 |
Last Verified: | September 2018 |
pediatric dietary treatment celiac disease T1D |
Celiac Disease Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Autoimmune Diseases Immune System Diseases Malabsorption Syndromes Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |