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Trial record 23 of 40 for:    Recruiting, Not yet recruiting, Available Studies | "Dyspepsia"

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

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ClinicalTrials.gov Identifier: NCT03089632
Recruitment Status : Recruiting
First Posted : March 24, 2017
Last Update Posted : December 20, 2017
Sponsor:
Information provided by (Responsible Party):
McMaster University

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Gastroparesis Dyspepsia Gluten Sensitivity Other: Gluten-free diet Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Before and after clinical trial.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Gluten-free Diet on Upper Gastrointestinal Symptoms in Type 1 Diabetic Patients With Dyspepsia-like Symptoms
Actual Study Start Date : December 15, 2017
Estimated Primary Completion Date : June 1, 2018
Estimated Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

Arm Intervention/treatment
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.
Other: Gluten-free diet
One-month gluten-free diet




Primary Outcome Measures :
  1. Changes in upper gastrointestinal symptoms assessed by the Leeds short-form questionnaire (SF-LDQ) [ Time Frame: 1 month ]
    Difference in upper gastrointestinal symptoms' severity (before and after the dietary intervention) assessed by the Leeds short-form questionnaire (SF-LDQ)

  2. Changes in upper gastrointestinal symptoms assessed by the Gastroparesis Cardinal Symptoms Index (GCSI) [ Time Frame: 1 month ]
    Difference in upper gastrointestinal symptoms' severity (before and after the dietary intervention) assessed by the Gastroparesis Cardinal Symptoms Index (GCSI).


Secondary Outcome Measures :
  1. Changes in gastric emptying determined by gastric scintigraphy. [ Time Frame: 1 month ]
    Difference in gastric emptying (before and after the intervention) determined by gastric scintigraphy.

  2. Changes in gastro-duodenal motility assessed by videofluoroscopy [ Time Frame: 1 month ]
    Differences in gastro-duodenal contraction patterns (before and after the intervention) assessed by videofluoroscopy.

  3. Changes in glycemic control assessed by continuous glucose monitoring [ Time Frame: 1 month ]
    Differences in continous glucose monitoring (before and after the intervention) assessed by 6-day continuous glucose monitoring



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03089632


Contacts
Contact: Premysl Bercik, MD, PhD 1 905 521 2100 ext 73495 bercikp@mcmaster.ca
Contact: Natalia Causada Calo, MD 9059030215 causadan@mcmaster.ca

Locations
Canada, Ontario
McMaster Health Sciences Centre Recruiting
Hamilton, Ontario, Canada, L8N3Z5
Contact: Natalia Causada Calo, MD    9059020215    causadan@mcmaster.ca   
Sub-Investigator: María Inés Pinto-Sánchez, MD         
Sub-Investigator: Suzanne Hansen, Dietician         
Sub-Investigator: Natalia Causada Calo, MD         
Principal Investigator: Premysl Bercik, MD, PhD         
Sponsors and Collaborators
McMaster University
Investigators
Principal Investigator: Premysl Bercik, MD, PhD McMaster University, Department of Medicine, Division of Gastroenterology

Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT03089632     History of Changes
Other Study ID Numbers: DM1 and GFD_01
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: December 20, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by McMaster University:
gluten-free diet
gluten sensitivity
dyspepsia
diabetes mellitus, type 1
gastroparesis
motility

Additional relevant MeSH terms:
Dyspepsia
Diabetes Mellitus
Hypersensitivity
Diabetes Mellitus, Type 1
Gastroparesis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Immune System Diseases
Autoimmune Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations