This study is being conducted to understand whether the withdrawal of gluten from the diet will help improve digestive symptoms in patients with type 1 diabetes (T1DM). Also, it will determine if gluten-free diet helps normalizing gastric emptying which influences blood sugar control.
Patients with T1DM and celiac disease (CD) are genetically related as the same genes, HLA genes DQ2 and DQ8 genes, confer higher risk to develop both T1DM and CD. Moreover, gluten-free diet (GFD) improves intestinal inflammation and normalizes digestive symptoms in patients with CD. However, it is unknown if T1DM patients who suffer from frequent digestive symptoms, could benefit from removing gluten from their diet.
We ask the participants of this study to follow a one-month gluten-free diet, supervised by a specialized dietician.
Who is eligible to participate?
- Adult patients (≥18 y) with type 1 diabetes and without celiac disease
- With one or more of the following symptoms: nausea, vomiting, upper abdominal pain, post-prandial fullness, early satiety, bloating
What will the study measure?
- Intestinal symptoms and general health and wellbeing scores, using questionnaires
- Gastric emptying, assessed by two different clinical exams
- Sugar levels, using the FreeStyle Libre continuous monitoring device
- Inflammatory markers triggered by gluten/wheat in blood
- The presence/absence of the two gene markers HLA DQ2 and DQ8
- Intestinal microbiome (bacteria flora) composition
Will there be any samples being collected?
- Two blood samples
- Two stool samples
What is the total duration of the study and the number of visits?
- Duration of visits: 6-7 weeks
- Number of Visits: 5 visits/appointments at McMaster Children’s Hospital, Hamilton
Will there be a compensation to participate?
We will offer compensation and all the costs for the study visits will be covered.
Dr. Premysl Bercik (Principal Investigator), Dr. Gaston Rueda (research staff), Dr Pedro Miranda (research staff)
Gaston Rueda, firstname.lastname@example.org
Pedro Miranda, email@example.com