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

Primary Purpose

Celiac Disease, Diabetes Mellitus, Type 1

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Gluten Free Diet
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Celiac Disease focused on measuring pediatric, dietary treatment, celiac disease, T1D

Eligibility Criteria

8 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Diet Intervention Group

Control Group

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
March 27, 2012
Last Updated
September 4, 2018
Sponsor
The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT01566110
Brief Title
Celiac Disease and Diabetes- Dietary Intervention and Evaluation Trial
Acronym
CD-DIET
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 Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Celiac Disease, Diabetes Mellitus, Type 1
Keywords
pediatric, dietary treatment, celiac disease, T1D

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diet Intervention Group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Gluten Free Diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Metabolic Control
Description
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.
Time Frame
Change from Baseline over 1 year
Secondary Outcome Measure Information:
Title
Hypoglycemic Episodes
Description
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.
Time Frame
Frequency over 12 months
Title
Continuous Glucose Monitoring
Description
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.
Time Frame
Baseline, 6 months and 12 months after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Farid Mahmud, MD
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Kingston General Hospital
City
Kingston
State/Province
Ontario
Country
Canada
Facility Name
London Health Sciences
City
London
State/Province
Ontario
Country
Canada
Facility Name
St. Joseph's Healthcare
City
London
State/Province
Ontario
Country
Canada
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5V1X8
Country
Canada
Facility Name
LMC Diabetes and Endocrinology
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
35176765
Citation
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.
Results Reference
derived
PubMed Identifier
33852450
Citation
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.
Results Reference
derived
PubMed Identifier
33524131
Citation
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.
Results Reference
derived
PubMed Identifier
32345653
Citation
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.
Results Reference
derived
PubMed Identifier
26692164
Citation
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.
Results Reference
derived
PubMed Identifier
25968008
Citation
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.
Results Reference
derived

Learn more about this trial

Celiac Disease and Diabetes- Dietary Intervention and Evaluation Trial

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