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

N/A
Waitlist Available
Led By Premysl Bercik, MD, PhD
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* 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.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Diabetes
  • Delayed Gastric Emptying
  • Indigestion
  • Gastroparesis
  • Type 1 Diabetes
  • Gluten Intolerance

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changes in upper gastrointestinal symptoms assessed by the Gastroparesis Cardinal Symptoms Index (GCSI)
Changes in upper gastrointestinal symptoms assessed by the Leeds short-form questionnaire (SF-LDQ)
Secondary study objectives
Changes in gastric emptying determined by gastric scintigraphy.
Changes in gastro-duodenal motility assessed by videofluoroscopy
Changes in glycemic control assessed by continuous glucose monitoring

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Gluten-free dietExperimental Treatment1 Intervention
All patients will follow a strict gluten-free diet for 1 month. Measurement will be conducted at baseline and after the intervention.

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Who is running the clinical trial?

McMaster UniversityLead Sponsor
918 Previous Clinical Trials
2,616,263 Total Patients Enrolled
8 Trials studying Diabetes
4,489 Patients Enrolled for Diabetes
Premysl Bercik, MD, PhDPrincipal InvestigatorMcMaster University, Department of Medicine, Division of Gastroenterology
1 Previous Clinical Trials
20 Total Patients Enrolled
~4 spots leftby Dec 2025
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