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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gluten-free diet | Experimental | All patients will follow a strict gluten-free diet for 1 month. Measurement will be conducted at baseline and after the intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gluten-free diet | Other | One-month gluten-free diet |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 1 month |
| 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). | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in gastric emptying determined by gastric scintigraphy. | Difference in gastric emptying (before and after the intervention) determined by gastric scintigraphy. | 1 month |
| Changes in gastro-duodenal motility assessed by videofluoroscopy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Premysl Bercik, MD, PhD | Contact | 1 905 521 2100 | 73495 | bercikp@mcmaster.ca |
| Natalia Causada Calo, MD | Contact | 9059030215 | causadan@mcmaster.ca |
| Name | Affiliation | Role |
|---|---|---|
| Premysl Bercik, MD, PhD | McMaster University, Department of Medicine, Division of Gastroenterology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster Health Sciences Centre | Recruiting | Hamilton | Ontario | L8N3Z5 | Canada |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D018589 | Gastroparesis |
| D004415 | Dyspepsia |
| D002446 | Celiac Disease |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D055050 | Diet, Gluten-Free |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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Before and after clinical trial.
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Differences in gastro-duodenal contraction patterns (before and after the intervention) assessed by videofluoroscopy.
| 1 month |
| 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 | 1 month |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |