Diabetes Mellitus, Type 1, Dyspepsia, Gastroparesis, Gluten Sensitivity
Conditions
Keywords
gluten-free diet, gluten sensitivity, dyspepsia, diabetes mellitus, type 1, gastroparesis, motility
Brief summary
Patients with type-1 diabetes are more susceptible to motility-related upper gastrointestinal symptoms. Dietary interventions are one of the treatment pillars for these symptoms. Many gastrointestinal conditions other than celiac disease, are being increasingly treated with gluten-free diet (GFD). The role of GFD in non-celiac type-1 diabetic patients with dyspepsia-like symptoms has not been assessed before. In this study, type 1 diabetes patients with concomitant upper gastrointestinal symptoms will be asked to follow a 1-month GFD to assess changes in upper gastrointestinal symptoms and gastroduodenal motility before and after the dietary intervention.
Detailed description
Diabetes mellitus (DM) is a complex and heterogeneous disease that is associated with poor outcomes. In studies from referral centers, 50-65% of diabetics reported dyspeptic symptoms. In addition, approximately 50% of type 1 DM (T1DM) patients, especially those with longstanding disease, have evidence of delayed gastric emptying. Dietary modification is one of the treatment pillars for patients with dyspeptic symptoms. Further, many individuals in which both symptoms and motility abnormalities improve after a GFD have positive anti-gliadin antibodies (AGA), which reinforces the role of gluten-induced inflammation/immune activation as a possible cause of motility abnormalities and related symptoms. Ameliorating UGI symptoms is not only pivotal for improving the quality of life of diabetic GP patients, but the improvement in gastroduodenal motility is also needed for a more predictable glycemic response. In non-celiac T1DM patients, the role of the GFD in symptom improvement, gastroduodenal motility and glycemic control has never been assessed. The overall aim of the present study is to improve the knowledge about the role of dietary interventions as non-pharmacological treatments for upper-gastrointestinal symptoms and underlying motility abnormalities in patients with type 1 diabetes. This will be a non-randomized, open label, before and after trial of a 1-month GFD in non-celiac type 1 diabetics to assess symptomatic, motility and glycemic response changes.
Interventions
OTHERGluten-free diet
One-month gluten-free diet
Sponsors
McMaster University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Before and after clinical trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Adult men and women (18-75 years) with type 1 diabetes diagnosis and no history of celiac disease, that complain of upper gastrointestinal symptoms (early satiety, postprandial fullness, bloating, abdominal swelling, nausea, vomiting, and retching) will be invited to participate.
Exclusion criteria
* Patients with very severe symptoms of gastroparesis that require specialized nutritional therapy or surgical treatment; * Pregnant women; * Patients with concomitant diseases/treatments that can alter gastrointestinal motility and concomitant severe systemic diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in upper gastrointestinal symptoms assessed by the Leeds short-form questionnaire (SF-LDQ) | 1 month | Difference in upper gastrointestinal symptoms' severity (before and after the dietary intervention) assessed by the Leeds short-form questionnaire (SF-LDQ) |
| Changes in upper gastrointestinal symptoms assessed by the Gastroparesis Cardinal Symptoms Index (GCSI) | 1 month | Difference in upper gastrointestinal symptoms' severity (before and after the dietary intervention) assessed by the Gastroparesis Cardinal Symptoms Index (GCSI). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in gastric emptying determined by gastric scintigraphy. | 1 month | Difference in gastric emptying (before and after the intervention) determined by gastric scintigraphy. |
| Changes in gastro-duodenal motility assessed by videofluoroscopy | 1 month | Differences in gastro-duodenal contraction patterns (before and after the intervention) assessed by videofluoroscopy. |
| Changes in glycemic control assessed by continuous glucose monitoring | 1 month | Differences in continous glucose monitoring (before and after the intervention) assessed by 6-day continuous glucose monitoring |
Countries
Canada
Contacts
Primary ContactPremysl Bercik, MD, PhD
Backup ContactNatalia Causada Calo, MD
Outcome results
None listed