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Celiac Disease and Diabetes- Dietary Intervention and Evaluation Trial (CD-DIET)

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ClinicalTrials.gov Identifier: NCT01566110
Recruitment Status : Completed
First Posted : March 29, 2012
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Farid Mahmud, The Hospital for Sick Children

Study Description
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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.

Condition or disease Intervention/treatment Phase
Celiac Disease Diabetes Mellitus, Type 1 Dietary Supplement: Gluten Free Diet Not Applicable

Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   8 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects must meet each of the following criteria for inclusion into the study:

  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:

  1. Prior diagnosis of CD.

  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
  3. 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.
  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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
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Principal Investigator: Farid Mahmud, MD The Hospital for Sick Children
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Keywords provided by Farid Mahmud, The Hospital for Sick Children:
pediatric
dietary treatment
celiac disease
T1D
Additional relevant MeSH terms:
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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