Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2026-01-03 @ 1:45 AM
Study NCT ID:
NCT03089632
Status:
UNKNOWN
Last Update Posted:
2017-12-20
First Post:
2017-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Gluten-free Diet in Type 1 Diabetics With Dyspepsia Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D018589', 'term': 'Gastroparesis'}, {'id': 'D004415', 'term': 'Dyspepsia'}, {'id': 'D002446', 'term': 'Celiac Disease'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D008286', 'term': 'Malabsorption Syndromes'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055050', 'term': 'Diet, Gluten-Free'}], 'ancestors': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Before and after clinical trial.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2018-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-12-18', 'studyFirstSubmitDate': '2017-03-15', 'studyFirstSubmitQcDate': '2017-03-23', 'lastUpdatePostDateStruct': {'date': '2017-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in upper gastrointestinal symptoms assessed by the Leeds short-form questionnaire (SF-LDQ)', 'timeFrame': '1 month', 'description': "Difference in upper gastrointestinal symptoms' severity (before and after the dietary intervention) assessed by the Leeds short-form questionnaire (SF-LDQ)"}, {'measure': 'Changes in upper gastrointestinal symptoms assessed by the Gastroparesis Cardinal Symptoms Index (GCSI)', 'timeFrame': '1 month', 'description': "Difference in upper gastrointestinal symptoms' severity (before and after the dietary intervention) assessed by the Gastroparesis Cardinal Symptoms Index (GCSI)."}], 'secondaryOutcomes': [{'measure': 'Changes in gastric emptying determined by gastric scintigraphy.', 'timeFrame': '1 month', 'description': 'Difference in gastric emptying (before and after the intervention) determined by gastric scintigraphy.'}, {'measure': 'Changes in gastro-duodenal motility assessed by videofluoroscopy', 'timeFrame': '1 month', 'description': 'Differences in gastro-duodenal contraction patterns (before and after the intervention) assessed by videofluoroscopy.'}, {'measure': 'Changes in glycemic control assessed by continuous glucose monitoring', 'timeFrame': '1 month', 'description': 'Differences in continous glucose monitoring (before and after the intervention) assessed by 6-day continuous glucose monitoring'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gluten-free diet', 'gluten sensitivity', 'dyspepsia', 'diabetes mellitus, type 1', 'gastroparesis', 'motility'], 'conditions': ['Diabetes Mellitus, Type 1', 'Gastroparesis', 'Dyspepsia', 'Gluten Sensitivity']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nDietary 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.\n\nAmeliorating 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* Patients with very severe symptoms of gastroparesis that require specialized nutritional therapy or surgical treatment;\n* Pregnant women;\n* Patients with concomitant diseases/treatments that can alter gastrointestinal motility and concomitant severe systemic diseases.'}, 'identificationModule': {'nctId': 'NCT03089632', 'briefTitle': 'The Effect of Gluten-free Diet in Type 1 Diabetics With Dyspepsia Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'The Effect of Gluten-free Diet on Upper Gastrointestinal Symptoms in Type 1 Diabetic Patients With Dyspepsia-like Symptoms', 'orgStudyIdInfo': {'id': 'DM1 and GFD_01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gluten-free diet', 'description': 'All patients will follow a strict gluten-free diet for 1 month. Measurement will be conducted at baseline and after the intervention.', 'interventionNames': ['Other: Gluten-free diet']}], 'interventions': [{'name': 'Gluten-free diet', 'type': 'OTHER', 'description': 'One-month gluten-free diet', 'armGroupLabels': ['Gluten-free diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8N3Z5', 'city': 'Hamilton', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Natalia Causada Calo, MD', 'role': 'CONTACT', 'email': 'causadan@mcmaster.ca', 'phone': '9059020215'}, {'name': 'María Inés Pinto-Sánchez, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Suzanne Hansen, Dietician', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Natalia Causada Calo, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Premysl Bercik, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'McMaster Health Sciences Centre', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'centralContacts': [{'name': 'Premysl Bercik, MD, PhD', 'role': 'CONTACT', 'email': 'bercikp@mcmaster.ca', 'phone': '1 905 521 2100', 'phoneExt': '73495'}, {'name': 'Natalia Causada Calo, MD', 'role': 'CONTACT', 'email': 'causadan@mcmaster.ca', 'phone': '9059030215'}], 'overallOfficials': [{'name': 'Premysl Bercik, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University, Department of Medicine, Division of Gastroenterology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McMaster University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}