Clinical trial NCT01566110: Celiac Disease and Diabetes- Dietary Intervention and Evaluation Trial
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
Overall status: COMPLETED
Phase: NA
Conditions: Celiac Disease
Diabetes Mellitus, Type 1
Keywords: pediatric
dietary treatment
celiac disease
T1D
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2012-03-29
Enrollment: 50
Sex: ALL
Minimum age (years): 8
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Metabolic Control
timeFrame: Change from Baseline over 1 year
Secondary outcomes:
measure: Hypoglycemic Episodes
timeFrame: Frequency over 12 months
measure: Continuous Glucose Monitoring
timeFrame: Baseline, 6 months and 12 months after randomization
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences
state: Ontario
city: London
country: Canada
facility: St. Joseph's Healthcare
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Toronto
country: Canada
facility: LMC Diabetes and Endocrinology
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Farid Mahmud, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.