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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 : 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

Tracking Information
First Submitted Date  ICMJE March 27, 2012
First Posted Date  ICMJE March 29, 2012
Last Update Posted Date September 5, 2018
Study Start Date  ICMJE March 2012
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2012)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Celiac Disease and Diabetes- Dietary Intervention and Evaluation Trial
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Celiac Disease
  • Diabetes Mellitus, Type 1
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Diet Intervention Group
    Intervention: Dietary Supplement: 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 12, 2017)
50
Original Estimated Enrollment  ICMJE
 (submitted: March 27, 2012)
200
Actual Study Completion Date  ICMJE March 2018
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01566110
Other Study ID Numbers  ICMJE 1000030346
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Farid Mahmud, The Hospital for Sick Children
Study Sponsor  ICMJE The Hospital for Sick Children
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Farid Mahmud, MD The Hospital for Sick Children
PRS Account The Hospital for Sick Children
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP