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Celiac DiseaseCD-DIETNCT01566110

Celiac Disease and Diabetes- Dietary Intervention and Evaluation Trial

A study testing Gluten Free Diet in people with Celiac Disease and Diabetes Mellitus, Type 1, run by The Hospital for Sick Children at 7 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 8 to 45 years
Conditions the study is for
Celiac Disease, Diabetes Mellitus, Type 1
What is being tested?
Gluten Free Diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
7 sitesCanada
Study dates
Mar 2012to Mar 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 45 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • Prior diagnosis of CD.
  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Canada7 sites

  • McMaster University

    Hamilton, Ontario

  • Kingston General Hospital

    Kingston, Ontario

  • London Health Sciences

    London, Ontario

  • St. Joseph's Healthcare

    London, Ontario

  • The Ottawa Hospital

    Ottawa, Ontario

  • The Hospital for Sick Children

    Toronto, Ontario, M5V1X8

  • LMC Diabetes and Endocrinology

    Toronto, Ontario

Other trials in Canada

About this study

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)

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.

Being tested
Gluten Free Diet
Keywords
pediatric, dietary treatment, celiac disease, T1D
Medical subject headings
Celiac Disease, Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gluten Free DietDietary supplement

    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 groups in NCT01566110
Study groupRoleWhat they receive
Diet Intervention GroupExperimentalNot described
Receives: Dietary Supplement: Gluten Free Diet
Control GroupNo interventionSubjects 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Metabolic Control

    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.

    Measured: Change from Baseline over 1 year

Secondary outcomes (2)

  1. Hypoglycemic Episodes

    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.

    Measured: Frequency over 12 months

  2. Continuous Glucose Monitoring

    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.

    Measured: Baseline, 6 months and 12 months after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionMar 2018
  4. Study completionMar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01566110
Sponsor's protocol ID
1000030346
Acronym
CD-DIET
Status last verified
Sep 2018
First submitted
27 Mar 2012
Last updated
5 Sep 2018
Results posted
No
Data monitoring committee
No

Publications

  • De Melo EN, Clarke ABM, McDonald C, Saibil F, Lochnan HA, Punthakee Z, Assor E, Marcon MA, Mahmud FH. Gastrointestinal Symptoms in Type 1 Diabetes: Relationship With Autoimmune and Microvascular Complications. J Clin Endocrinol Metab. 2022 May 17;107(6):e2431-e2437. doi: 10.1210/clinem/dgac093.

    PubMed 35176765

  • Gould MJ, Mahmud FH, Clarke ABM, McDonald C, Saibil F, Punthakee Z, Marcon MA. Accuracy of Screening Tests for Celiac Disease in Asymptomatic Patients With Type 1 Diabetes. Am J Gastroenterol. 2021 Jul 1;116(7):1545-1549. doi: 10.14309/ajg.0000000000001193.

    PubMed 33852450

  • Weiman DI, Mahmud FH, Clarke ABM, Assor E, McDonald C, Saibil F, Lochnan HA, Punthakee Z, Marcon MA; CD-DIET Study Group. Impact of a Gluten-Free Diet on Quality of Life and Health Perception in Patients With Type 1 Diabetes and Asymptomatic Celiac Disease. J Clin Endocrinol Metab. 2021 Apr 23;106(5):e1984-e1992. doi: 10.1210/clinem/dgaa977.

    PubMed 33524131

  • Mahmud FH, Clarke ABM, Joachim KC, Assor E, McDonald C, Saibil F, Lochnan HA, Punthakee Z, Parikh A, Advani A, Shah BR, Perkins BA, Zuijdwijk CS, Mack DR, Koltin D, De Melo EN, Hsieh E, Mukerji G, Gilbert J, Bax K, Lawson ML, Cino M, Beaton MD, Saloojee NA, Lou O, Gallego PH, Bercik P, Houlden RL, Aronson R, Kirsch SE, Paterson WG, Marcon MA. Screening and Treatment Outcomes in Adults and Children With Type 1 Diabetes and Asymptomatic Celiac Disease: The CD-DIET Study. Diabetes Care. 2020 Jul;43(7):1553-1556. doi: 10.2337/dc19-1944. Epub 2020 Apr 28.

    PubMed 32345653

  • Assor E, Marcon MA, Hamilton N, Fry M, Cooper T, Mahmud FH. Design of a dietary intervention to assess the impact of a gluten-free diet in a population with type 1 Diabetes and Celiac Disease. BMC Gastroenterol. 2015 Dec 21;15:181. doi: 10.1186/s12876-015-0413-0.

    PubMed 26692164

  • Mahmud FH, De Melo EN, Noordin K, Assor E, Sahota K, Davies-Shaw J, Cutz E, Somers G, Lawson M, Mack DR, Gallego P, McDonald C, Beaton MD, Bax K, Saibil F, Gilbert J, Kirsch S, Perkins BA, Cino M, Szentgyorgyi E, Koltin D, Parikh A, Mukerji G, Advani A, Lou O, Marcon MA. The Celiac Disease and Diabetes-Dietary Intervention and Evaluation Trial (CD-DIET) protocol: a randomised controlled study to evaluate treatment of asymptomatic coeliac disease in type 1 diabetes. BMJ Open. 2015 May 11;5(5):e008097. doi: 10.1136/bmjopen-2015-008097.

    PubMed 25968008

Questions about this trial

What is this clinical trial studying?

A study testing Gluten Free Diet in people with Celiac Disease and Diabetes Mellitus, Type 1, run by The Hospital for Sick Children at 7 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Metabolic Control (time frame: Change from Baseline over 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01566110, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2018.

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