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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03089632
• Other study ID #: DM1 and GFD_01
• Status: Recruiting
• Phase: N/A
• First received: March 15, 2017
• Last updated: December 18, 2017
• Start date: December 15, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: December 2017
• Source: McMaster University
• Contact: Premysl Bercik, MD, PhD
• Phone: 1 905 521 2100
• Email: bercikp[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 30, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Dyspepsia
• Gastroparesis
• Gluten Sensitivity
• Hypersensitivity

Intervention

Other:
• Gluten-free diet
One-month gluten-free diet

Locations

Country	Name	City	State
Canada	McMaster Health Sciences Centre	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in upper gastrointestinal symptoms assessed by the Leeds short-form questionnaire (SF-LDQ)	Difference in upper gastrointestinal symptoms' severity (before and after the dietary intervention) assessed by the Leeds short-form questionnaire (SF-LDQ)	1 month
Primary	Changes in upper gastrointestinal symptoms assessed by the Gastroparesis Cardinal Symptoms Index (GCSI)	Difference in upper gastrointestinal symptoms' severity (before and after the dietary intervention) assessed by the Gastroparesis Cardinal Symptoms Index (GCSI).	1 month
Secondary	Changes in gastric emptying determined by gastric scintigraphy.	Difference in gastric emptying (before and after the intervention) determined by gastric scintigraphy.	1 month
Secondary	Changes in gastro-duodenal motility assessed by videofluoroscopy	Differences in gastro-duodenal contraction patterns (before and after the intervention) assessed by videofluoroscopy.	1 month
Secondary	Changes in glycemic control assessed by continuous glucose monitoring	Differences in continous glucose monitoring (before and after the intervention) assessed by 6-day continuous glucose monitoring	1 month