Clinical trial NCT03089632: The Effect of Gluten-free Diet in Type 1 Diabetics With Dyspepsia Symptoms
Official title: The Effect of Gluten-free Diet on Upper Gastrointestinal Symptoms in Type 1 Diabetic Patients With Dyspepsia-like Symptoms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Gastroparesis
Dyspepsia
Gluten Sensitivity
Keywords: gluten-free diet
gluten sensitivity
dyspepsia
diabetes mellitus, type 1
gastroparesis
motility
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2017-03-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Before and after clinical trial.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in upper gastrointestinal symptoms assessed by the Leeds short-form questionnaire (SF-LDQ)
timeFrame: 1 month
measure: Changes in upper gastrointestinal symptoms assessed by the Gastroparesis Cardinal Symptoms Index (GCSI)
timeFrame: 1 month
Secondary outcomes:
measure: Changes in gastric emptying determined by gastric scintigraphy.
timeFrame: 1 month
measure: Changes in gastro-duodenal motility assessed by videofluoroscopy
timeFrame: 1 month
measure: Changes in glycemic control assessed by continuous glucose monitoring
timeFrame: 1 month
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster Health Sciences Centre
state: Ontario
Study officials:
affiliation: McMaster University, Department of Medicine, Division of Gastroenterology
name: Premysl Bercik, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: