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

This study is currently recruiting participants.
Verified August 2013 by The Hospital for Sick Children
Sponsor:
Information provided by (Responsible Party):
Farid Mahmud, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01566110
First received: March 27, 2012
Last updated: August 6, 2013
Last verified: August 2013
  Purpose

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 Intervention
Celiac Disease
Diabetes Mellitus, Type 1
Dietary Supplement: Gluten Free Diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Metabolic Control [ Time Frame: Change from Baseline over 1 year ] [ Designated as safety issue: No ]
    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:
  • Hypoglycemic Episodes [ Time Frame: Frequency over 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 200
Study Start Date: March 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   8 Years to 35 Years
Genders Eligible for Study:   Both
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 35 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01566110

Contacts
Contact: Farid Mahmud, MD 416-813-6218 farid.mahmud@sickkids.ca

Locations
Canada, Ontario
London Health Sciences Recruiting
London, Ontario, Canada
Contact: Marge Lovell    519-685-8500 ext 77548    marg.lovell@lhsc.on.ca   
St. Joseph's Healthcare Recruiting
London, Ontario, Canada
Contact: Charlotte McDonald, MD    519-646-6170    charlotte.mcdonald@sjhc.london.on.ca   
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5V1X8
Principal Investigator: Farid Mahmud, MD         
Canada
Children's Hospital London Health Sciences Recruiting
London, Canada
Contact: Patricia Gallego, MD    519-685-8500 ext 58139    patricia.gallego@lhsc.on.ca   
Children's Hospital of Eastern Ontario Recruiting
Ottawa, Canada
Contact: Jennilea Courtney    613-737-7600 ext 4156    jcourtney@cheo.on.ca   
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Farid Mahmud, MD The Hospital for Sick Children
  More Information

No publications provided

Responsible Party: Farid Mahmud, Staff Physician, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01566110     History of Changes
Other Study ID Numbers: 1000030346
Study First Received: March 27, 2012
Last Updated: August 6, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
pediatric
dietary treatment
celiac disease
T1D

Additional relevant MeSH terms:
Celiac Disease
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases
Glucose Metabolism Disorders
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 1
Malabsorption Syndromes

ClinicalTrials.gov processed this record on April 20, 2014