Recruiting

Gluten-free Diet

Sponsor:

McMaster University

Code:

NCT03089632

Conditions

Diabetes Mellitus, Type 1

Gastroparesis

Dyspepsia

Gluten Sensitivity

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Gluten-free diet

Study Details

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.

Conditions

Diabetes Mellitus, Type 1

Gastroparesis

Dyspepsia

Gluten Sensitivity

Study ID

NCT03089632

Start date

Dec 15, 2017

Status verified date

Dec, 2017

Completion date

Jun 30, 2018

Anticipated

Primary completion date

Jun 1, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

Gluten-free diet

One-month gluten-free diet

Primary outcome measure

  • Changes in upper gastrointestinal symptoms assessed by the Leeds short-form questionnaire (SF-LDQ) [ Time Frame: 1 month ]
  • Changes in upper gastrointestinal symptoms assessed by the Gastroparesis Cardinal Symptoms Index (GCSI) [ Time Frame: 1 month ]

Central Contacts and Locations

Central contacts

Premysl Bercik, MD, PhD

1 905 521 2100bercikp@mcmaster.ca

Natalia Causada Calo, MD

9059030215causadan@mcmaster.ca

Locations

McMaster Health Sciences Centre

Recruiting

Hamilton, Ontario, Canada, L8N3Z5

Contacts

Natalia Causada Calo, MD

9059020215causadan@mcmaster.ca

Principal Investigator:

Premysl Bercik, MD, PhD

More Information

Sponsor

McMaster University

Last update posted

Dec 20, 2017

Last verified

Dec, 2017

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-11. This information was provided to ClinicalTrials.gov by McMaster University on 2017-12-20. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.