Dietary Intervention and Evaluation Trial (CD-DIET)
This study is currently recruiting participants.
Verified September 2012 by The Hospital for Sick Children
Sponsor:
The Hospital for Sick Children
Information provided by (Responsible Party):
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01566110
First received: March 27, 2012
Last updated: September 26, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Celiac Disease Diabetes Mellitus, Type 1 |
Dietary Supplement: Gluten Free Diet |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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) |
Resource links provided by NLM:
Further study details as provided by The Hospital for Sick Children:
Primary Outcome Measures:
- Metabolic Control [ Time Frame: Change from Baseline over 1 year ] [ Designated as safety issue: No ]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 [ Time Frame: Frequency over 12 months ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline, 6 months and 12 months after randomization ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 200 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
Eligibility| Ages Eligible for Study: | 8 Years to 35 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Subjects must meet each of the following criteria for inclusion into the study:
- Males and females age between 8 and 35 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01566110
Contacts
| Contact: Farid Mahmud, MD | 416-813-6218 | farid.mahmud@sickkids.ca |
Locations
| Canada, Ontario | |
| London Health Sciences | Recruiting |
| London, Ontario, Canada | |
| Contact: Marge Lovell 519-685-8500 ext 77548 marg.lovell@lhsc.on.ca | |
| St. Joseph's Healthcare | Recruiting |
| London, Ontario, Canada | |
| Contact: Charlotte McDonald, MD 519-646-6170 charlotte.mcdonald@sjhc.london.on.ca | |
| The Hospital for Sick Children | Recruiting |
| Toronto, Ontario, Canada, M5V1X8 | |
| Principal Investigator: Farid Mahmud, MD | |
| Canada | |
| Children's Hospital London Health Sciences | Recruiting |
| London, Canada | |
| Contact: Patricia Gallego, MD 519-685-8500 ext 58139 patricia.gallego@lhsc.on.ca | |
| Children's Hospital of Eastern Ontario | Recruiting |
| Ottawa, Canada | |
| Contact: Jennilea Courtney 613-737-7600 ext 4156 jcourtney@cheo.on.ca | |
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
| Principal Investigator: | Farid Mahmud, MD | The Hospital for Sick Children |
More Information
No publications provided
| Responsible Party: | The Hospital for Sick Children |
| ClinicalTrials.gov Identifier: | NCT01566110 History of Changes |
| Other Study ID Numbers: | 1000030346 |
| Study First Received: | March 27, 2012 |
| Last Updated: | September 26, 2012 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by The Hospital for Sick Children:
|
pediatric dietary treatment celiac disease T1D |
Additional relevant MeSH terms:
|
Celiac Disease Diabetes Mellitus Diabetes Mellitus, Type 1 Malabsorption Syndromes Intestinal Diseases Gastrointestinal Diseases |
Digestive System Diseases Metabolic Diseases Glucose Metabolism Disorders Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013