Design of a dietary intervention to assess the impact of a gluten-free diet in a population with type 1 Diabetes and Celiac Disease.
Study Goal
The researchers aimed to evaluate the safety and efficacy of a Gluten-Free Diet (GFD) in patients with asymptomatic celiac disease and type-1 diabetes, focusing on metabolic control, bone health, and quality of life.
Results Summary
The study designed a dietary curriculum to assess GFD adherence and its impact on diabetes and patient-centered outcomes, but specific results regarding efficacy are not detailed in the abstract.
Population
Patients with asymptomatic celiac disease and type-1 diabetes (children and adults).
Effective Dosage
Not specified
Duration
Not specified
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
Gluten-Free Diet (GFD) | neutral | key diabetes and patient-centered outcomes | patients with asymptomatic celiac disease and T1D | - | evaluating the safety and efficacy | #1 |
Gluten-Free Diet (GFD) | neutral | metabolic control | patients with CD and diabetes | - | facilitate evaluation | #2 |
Gluten-Free Diet (GFD) | neutral | bone health | patients with CD and diabetes | - | facilitate evaluation | #3 |
Gluten-Free Diet (GFD) | neutral | patient quality of life | patients with CD and diabetes | - | facilitate evaluation | #4 |
BACKGROUND: Celiac Disease occurs at a 5-10 fold greater prevalence in patients with type-1 diabetes (T1D), despite this increased risk, there is limited objective evidence regarding the impact of a Gluten-Free Diet (GFD) in the large proportion of asymptomatic (30-70%) patients with both autoimmune diseases. Given the requirements and intricacies inherent to each condition, we describe the rationale and design a dietary curriculum specifically addressing the educational requirements for children and adults with CD and diabetes as part of the CD-DIET Study. METHODS AND DESIGN: The CD-DIET Study (Celiac Disease and Diabetes - Dietary Intervention and Evaluation Trial) is a multicenter randomized controlled trial aimed at evaluating the safety and efficacy of a GFD in patients with asymptomatic celiac disease and T1D on key diabetes and patient-centered outcomes. DISCUSSION: Key dietary components of the trial include a description and evaluation of food consumption patterns including glycemic index and glycemic load, novel assessments of gluten quantification, and objective and subjective measures of GFD adherence. This dietary curriculum will establish rigorous guidelines to assess adherence and facilitate evaluation of a GFD on metabolic control, bone health and patient quality of life in patients with CD and diabetes. TRIAL REGISTRATION NUMBER: NCT01566110. Date of Registration: March, 2012.