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

NCT03089632 | Unknown

• 1 other identifier: DM1 and GFD_01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• Changes in gastric emptying determined by gastric scintigraphy.

  1 month

• Changes in gastro-duodenal motility assessed by videofluoroscopy

  1 month

• Changes in glycemic control assessed by continuous glucose monitoring

  1 month

Study Arms (1)

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.

Other: Gluten-free diet

Interventions

Gluten-free diet OTHER

One-month gluten-free diet

Gluten-free diet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster Health Sciences Centre

Hamilton, Ontario, L8N3Z5, Canada

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Gastroparesis; Dyspepsia; Celiac Disease

Interventions

Diet, Gluten-Free

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Malabsorption Syndromes; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Premysl Bercik, MD, PhD

  McMaster University, Department of Medicine, Division of Gastroenterology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Premysl Bercik, MD, PhD

CONTACT

1 905 521 2100; bercikp@mcmaster.ca

Natalia Causada Calo, MD

CONTACT

9059030215; causadan@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Before and after clinical trial.

Study Record Dates

• First Submitted: March 15, 2017
• First Posted: March 24, 2017
• Study Start: December 15, 2017
• Primary Completion: June 1, 2018
• Study Completion: June 30, 2018
• Last Updated: December 20, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)