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

September 4, 2018 updated by: Farid Mahmud, The Hospital for Sick Children

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada
        • McMaster University
      • Kingston, Ontario, Canada
        • Kingston General Hospital
      • London, Ontario, Canada
        • London Health Sciences
      • London, Ontario, Canada
        • St. Joseph's Healthcare
      • Ottawa, Ontario, Canada
        • The Ottawa Hospital
      • Toronto, Ontario, Canada, M5V1X8
        • The Hospital for Sick Children
      • Toronto, Ontario, Canada
        • LMC Diabetes and Endocrinology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from Baseline over 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Frequency over 12 months
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.
Baseline, 6 months and 12 months after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Investigators

  • Principal Investigator: Farid Mahmud, MD, The Hospital for Sick Children

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

March 27, 2012

First Submitted That Met QC Criteria

March 27, 2012

First Posted (Estimate)

March 29, 2012

Study Record Updates

Last Update Posted (Actual)

September 5, 2018

Last Update Submitted That Met QC Criteria

September 4, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000030346

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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