The Effect of Gluten-free Diet in Type 1 Diabetics With Dyspepsia Symptoms

Not Applicable

• Conditions: Diabetes Mellitus, Type 1; Gastroparesis; Gluten Sensitivity; Dyspepsia
• Interventions: Other: Gluten-free diet

• Registration Number: NCT03089632
• Lead Sponsor: McMaster University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-03-15
• Study First Submitted QC: 2017-03-23
• Study First Posted: 2017-03-24
• Status Verified: 2017-12
• Study Start: 2017-12-15
• Last Update Submitted: 2017-12-18
• Last Update Posted: 2017-12-20
• Primary Completion: 2018-06-01
• Study Completion: 2018-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gluten-free diet	Gluten-free diet	All patients will follow a strict gluten-free diet for 1 month. Measurement will be conducted at baseline and after the intervention.

Primary Outcome Measures

Name	Time	Method
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).
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)

Secondary Outcome Measures

Name	Time	Method
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 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
Changes in gastro-duodenal motility assessed by videofluoroscopy	1 month	Differences in gastro-duodenal contraction patterns (before and after the intervention) assessed by videofluoroscopy.

Trial Locations

Locations (1)

McMaster Health Sciences Centre; 🇨🇦 Hamilton, Ontario, Canada