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

Primary Purpose

Diabetes Mellitus, Type 1, Gastroparesis, Dyspepsia

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Gluten-free diet
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring gluten-free diet, gluten sensitivity, dyspepsia, diabetes mellitus, type 1, gastroparesis, motility

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • McMaster Health Sciences CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gluten-free diet

Arm Description

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

Outcomes

Primary Outcome Measures

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)
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).

Secondary Outcome Measures

Changes in gastric emptying determined by gastric scintigraphy.
Difference in gastric emptying (before and after the intervention) determined by gastric scintigraphy.
Changes in gastro-duodenal motility assessed by videofluoroscopy
Differences in gastro-duodenal contraction patterns (before and after the intervention) assessed by videofluoroscopy.
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

Full Information

First Posted
March 15, 2017
Last Updated
December 18, 2017
Sponsor
McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT03089632
Brief Title
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

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 15, 2017 (Actual)
Primary Completion Date
June 1, 2018 (Anticipated)
Study Completion Date
June 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1, Gastroparesis, Dyspepsia, Gluten Sensitivity
Keywords
gluten-free diet, gluten sensitivity, dyspepsia, diabetes mellitus, type 1, gastroparesis, motility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Before and after clinical trial.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gluten-free diet
Arm Type
Experimental
Arm Description
All patients will follow a strict gluten-free diet for 1 month. Measurement will be conducted at baseline and after the intervention.
Intervention Type
Other
Intervention Name(s)
Gluten-free diet
Intervention Description
One-month gluten-free diet
Primary Outcome Measure Information:
Title
Changes in upper gastrointestinal symptoms assessed by the Leeds short-form questionnaire (SF-LDQ)
Description
Difference in upper gastrointestinal symptoms' severity (before and after the dietary intervention) assessed by the Leeds short-form questionnaire (SF-LDQ)
Time Frame
1 month
Title
Changes in upper gastrointestinal symptoms assessed by the Gastroparesis Cardinal Symptoms Index (GCSI)
Description
Difference in upper gastrointestinal symptoms' severity (before and after the dietary intervention) assessed by the Gastroparesis Cardinal Symptoms Index (GCSI).
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Changes in gastric emptying determined by gastric scintigraphy.
Description
Difference in gastric emptying (before and after the intervention) determined by gastric scintigraphy.
Time Frame
1 month
Title
Changes in gastro-duodenal motility assessed by videofluoroscopy
Description
Differences in gastro-duodenal contraction patterns (before and after the intervention) assessed by videofluoroscopy.
Time Frame
1 month
Title
Changes in glycemic control assessed by continuous glucose monitoring
Description
Differences in continous glucose monitoring (before and after the intervention) assessed by 6-day continuous glucose monitoring
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Premysl Bercik, MD, PhD
Phone
1 905 521 2100
Ext
73495
Email
bercikp@mcmaster.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Natalia Causada Calo, MD
Phone
9059030215
Email
causadan@mcmaster.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Premysl Bercik, MD, PhD
Organizational Affiliation
McMaster University, Department of Medicine, Division of Gastroenterology
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster Health Sciences Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N3Z5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natalia Causada Calo, MD
Phone
9059020215
Email
causadan@mcmaster.ca
First Name & Middle Initial & Last Name & Degree
María Inés Pinto-Sánchez, MD
First Name & Middle Initial & Last Name & Degree
Suzanne Hansen, Dietician
First Name & Middle Initial & Last Name & Degree
Natalia Causada Calo, MD
First Name & Middle Initial & Last Name & Degree
Premysl Bercik, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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