Celiac Disease and Diabetes- Dietary Intervention and Evaluation Trial

Not Applicable

Completed

• Conditions: Celiac Disease; Diabetes Mellitus, Type 1
• Interventions: Dietary Supplement: Gluten Free Diet

• Registration Number: NCT01566110
• Lead Sponsor: The Hospital for Sick Children

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 available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-27
• Study First Submitted QC: 2012-03-27
• Study First Posted: 2012-03-29
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-04
• Last Update Posted: 2018-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diet Intervention Group	Gluten Free Diet	-

Primary Outcome Measures

Name	Time	Method
Metabolic Control	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.

Secondary Outcome Measures

Name	Time	Method
Continuous Glucose Monitoring	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.
Hypoglycemic Episodes	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.

Trial Locations

Locations (7)

McMaster University; 🇨🇦 Hamilton, Ontario, Canada

St. Joseph's Healthcare; 🇨🇦 London, Ontario, Canada

Kingston General Hospital; 🇨🇦 Kingston, Ontario, Canada

London Health Sciences; 🇨🇦 London, Ontario, Canada

LMC Diabetes and Endocrinology; 🇨🇦 Toronto, Ontario, Canada

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada