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
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 1 Gastroparesis Dyspepsia Gluten Sensitivity||Other: Gluten-free diet||Not Applicable|
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)|
|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|
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
- 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)
- 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).
- 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.
- 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.
- 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
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
|Contact: Premysl Bercik, MD, PhD||1 905 521 2100 ext firstname.lastname@example.org|
|Contact: Natalia Causada Calo, MDemail@example.com|
|McMaster Health Sciences Centre||Recruiting|
|Hamilton, Ontario, Canada, L8N3Z5|
|Contact: Natalia Causada Calo, MD 9059020215 firstname.lastname@example.org|
|Sub-Investigator: María Inés Pinto-Sánchez, MD|
|Sub-Investigator: Suzanne Hansen, Dietician|
|Sub-Investigator: Natalia Causada Calo, MD|
|Principal Investigator: Premysl Bercik, MD, PhD|
|Principal Investigator:||Premysl Bercik, MD, PhD||McMaster University, Department of Medicine, Division of Gastroenterology|