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

The Effect of Gluten-free Diet on Upper Gastrointestinal Symptoms in Type 1 Diabetic Patients With Dyspepsia-like Symptoms

Sponsors

Lead Sponsor: McMaster University

Source 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.

Overall Status Unknown status
Start Date December 15, 2017
Completion Date June 30, 2018
Primary Completion Date June 1, 2018
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Changes in upper gastrointestinal symptoms assessed by the Leeds short-form questionnaire (SF-LDQ) 1 month
Changes in upper gastrointestinal symptoms assessed by the Gastroparesis Cardinal Symptoms Index (GCSI) 1 month
Secondary Outcome
Measure Time Frame
Changes in gastric emptying determined by gastric scintigraphy. 1 month
Changes in gastro-duodenal motility assessed by videofluoroscopy 1 month
Changes in glycemic control assessed by continuous glucose monitoring 1 month
Enrollment 30
Condition
Intervention

Intervention Type: Other

Intervention Name: Gluten-free diet

Description: One-month gluten-free diet

Arm Group Label: Gluten-free diet

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Premysl Bercik, MD, PhD Principal Investigator McMaster University, Department of Medicine, Division of Gastroenterology
Overall Contact

Last Name: Premysl Bercik, MD, PhD

Phone: 1 905 521 2100

Phone Ext.: 73495

Email: [email protected]

Location
Facility: Status: Contact: Investigator: McMaster Health Sciences Centre Natalia Causada Calo, MD 9059020215 [email protected] María Inés Pinto-Sánchez, MD Sub-Investigator Suzanne Hansen, Dietician Sub-Investigator Natalia Causada Calo, MD Sub-Investigator Premysl Bercik, MD, PhD Principal Investigator
Location Countries

Canada

Verification Date

December 2017

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Gluten-free diet

Type: Experimental

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

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Intervention Model Description: Before and after clinical trial.

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov