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

NCT ID: NCT03089632

Last Updated: 2017-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-15

Study Completion Date

2018-06-30

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus, Type 1 Gastroparesis Dyspepsia Gluten Sensitivity

Keywords

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gluten-free diet gluten sensitivity dyspepsia diabetes mellitus, type 1 gastroparesis motility

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Before and after clinical trial.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Gluten-free diet

Intervention Type OTHER

One-month gluten-free diet

Interventions

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Gluten-free diet

One-month gluten-free diet

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Premysl Bercik, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University, Department of Medicine, Division of Gastroenterology

Locations

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McMaster Health Sciences Centre

Hamilton, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Premysl Bercik, MD, PhD

Role: CONTACT

Phone: 1 905 521 2100

Email: [email protected]

Natalia Causada Calo, MD

Role: CONTACT

Phone: 9059030215

Email: [email protected]

Facility Contacts

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Natalia Causada Calo, MD

Role: primary

Other Identifiers

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DM1 and GFD_01

Identifier Type: -

Identifier Source: org_study_id