International Society for Pediatric and Adolescent Diabetes
ISPAD 2014 | 40th Anniversary |
257
P168
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)
J. Davies-Shaw
1
, M.A. Marcon
2
, E. Assor
1
, E. Cutz
3
, K. Noordin
1
, K. Sahota
1
, A. Advani
4
, K. Bax
5
,
M.D. Beaton
6
, M. Cino
7
, P. Gallego
8
, J. Gilbert
9
, S. Kirsch
10
, D. Koltin
11
, M.L. Lawson
12
, D.R. Mack
13
,
C. McDonald
14
, G. Mukerji
15
, B.A. Perkins
16
, F. Saibil
17
, E. Szentgyorgi
18
, F.H. Mahmud
1
1
The Hospital for Sick Children, Division of Endocrinology, Toronto, Canada,
2
The Hospital for Sick
Children, Division of Gastroenterology, Hepatology and Nutrition, Toronto, Canada,
3
The Hospital for
Sick Children, Department of Pathology, Toronto, Canada,
4
St. Michael's Hospital, Division of
Endocrinology, Toronto, Canada,
5
Children's Hospital, London Health Sciences Centre, Pediatric
Gastroenterology, London, Canada,
6
London Health Sciences Centre, Division of Gastroenterology,
London, Canada,
7
Toronto Western Hospital, University Health Network, Division of Gastroenterology,
Toronto, Canada,
8
Children's Hospital, London Health Sciences Centre, Division of Endocrinology,
London, Canada,
9
Sunnybrook Health Sciences Centre, Division of Endocrinology and Metabolism,
Ontario, Canada,
10
Markham Stouffville Hospital, Division of Endocrinology, Markham, Canada,
11
Credit Valley Hospital, Trillium Health Partners, Division of Endocrinology, Toronto, Canada,
12
Children's Hospital of Eastern Ontario, Division of Endocrinology and Metabolism, Ottawa, Canada,
13
Children's Hospital of Eastern Ontario, Division of Gastroenterology, Hepatology and Nutrition,
Ottawa, Canada,
14
St. Joseph's Health Care, London Health Sciences Centre, Division of
Endocrinology and Metabolism, London, Canada,
15
Women's College Hospital, Division of
Endocrinology, Toronto, Canada,
16
Toronto General Hospital, University Health Network, Division of
Endocrinology and Metabolism, Toronto, Canada,
17
Sunnybrook Health Sciences Centre, Division of
Gastroenterology, Toronto, Canada,
18
Toronto General Hospital, University Health Network,
Department of Pathology, Toronto, Canada
Background:
Patients with Type 1 Diabetes (T1D) are at an increased risk for Celiac disease (CD)
with 5-7% of T1D patients presenting with both conditions. Many patients present without symptoms
and it is unclear whether the benefits of screening and treating asymptomatic individuals with a gluten-
free diet (GFD) outweigh the harms of imposing an additional diagnosis in patients already living with
T1D.
Objectives:
The CD-DIET study will evaluate the impact of screening and dietary management in
relation to clinically relevant outcomes, such as metabolic control, bone mineralization and well-being
in T1D patients (aged 8-45 years) who are asymptomatic and have biopsy-confirmed CD.
Methods:
CD-DIET is a multi-centre randomized controlled trial that will screen approximately 5000
T1D patients at pediatric and adult Ontario healthcare institutions as part of the JDRF-Canadian
Clinical Trial Network (JDRF-CCTN). T1D subjects, aged 8-45 years, identified with asymptomatic CD
(N=200) will be randomized to a dietary assignment of either the gluten-free diet treatment for one
year, or to a control group with a usual gluten-containing diet. Primary outcome is HbA1c at one year.
Secondary outcomes include bone mineralization measured by dual-energy X-ray absorptiometry
(DXA) of the lumbar spine, frequency of hypoglycemic episodes, blood glucose variability (by
continuous glucose monitoring); and self-reported health-related quality of life.
Results:
To date 1200 patients have been screened across Ontario, with a reported serology positivity
rate of 3.4% in pediatric patients and 6.1% in adult patients. Currently subjects are being randomized
into the intervention phase.
Conclusions:
Results from the CD-DIET Study will provide evidence-based guidelines for clinical
care, benefiting future individuals diagnosed with both T1D and asymptomatic CD, and will contribute
to knowledge and management of this dual diagnosis.
