Celiac Disease and Diabetes- Dietary Intervention and Evaluation Trial

Diabetes Mellitus, Type 1 Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01566110
• Other study ID #: 1000030346
• Status: Completed
• Phase: N/A
• Start date: March 2012
• Est. completion date: March 2018

Study information

• Verified date: September 2018
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Celiac Disease
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

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.

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario
Canada	Kingston General Hospital	Kingston	Ontario
Canada	London Health Sciences	London	Ontario
Canada	St. Joseph's Healthcare	London	Ontario
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	LMC Diabetes and Endocrinology	Toronto	Ontario
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from Baseline over 1 year
Secondary	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.	Frequency over 12 months
Secondary	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.	Baseline, 6 months and 12 months after randomization