Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-25 @ 7:54 PM
Study NCT ID:
NCT01940835
Status:
COMPLETED
Last Update Posted:
2022-02-02
First Post:
2013-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Role of Intestinal Inflammation in the Pathogenesis of Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005773', 'term': 'Gastroscopy'}, {'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D016099', 'term': 'Endoscopy, Gastrointestinal'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum, DNA, RNA extraction, brush biopsies from duodenal mucosa, biopsies of small intestine, stool samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2019-06-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-01', 'studyFirstSubmitDate': '2013-09-09', 'studyFirstSubmitQcDate': '2013-09-09', 'lastUpdatePostDateStruct': {'date': '2022-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-06-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Interleukin 15 (IL-15) Expression', 'timeFrame': 'baseline, 3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 1 Diabetes']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': "This purpose of this study is to determine if activation of a person's immune system in the small intestine could be a contributing cause of Type 1 Diabetes.", 'detailedDescription': 'There is a large body of literature hinting at a role of the gut in Type One Diabetes (T1D) pathogenesis. However, to the best of our knowledge there is no definitive evidence to date conclusively demonstrating a link. The only way to test this hypothesis is to have access to the intestinal tissue of T1D patients at very early stages when beta-islet cell destruction is still ongoing. Furthermore, to prepare for large prospective studies it is critical to determine whether there is a peripheral blood signature for intestinal inflammation. Finally, because enteroviral infections have been implicated in T1D pathogenesis, this study provides a unique opportunity to determine whether there is a dysregulated response to innate stimuli associated with viral infections and whether evidence of transcriptional signatures indicative of viral infections in the gut is correlated with disease. Finally, we will take advantage of this pilot study to collect samples that can be used for microbiome, virome and metabolic studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Type 1 Diabetes, diagnosed within 6 months', 'healthyVolunteers': True, 'eligibilityCriteria': 'For the Diabetes Cohort:\n\nInclusion Criteria:\n\n* Initial diagnosis for Type 1 Diabetes Mellitus (DM) must be within the past 6 months.\n* Clinical criteria used to diagnose T1D include at least some of the following : Diabetic ketoacidosis, Polyuria, Polydipsia, weight loss, need for insulin from diagnosis, BMI less than 30, C-peptide \\< 200 pmol/L or 0.6 ng/ml, Presence of Type 1 Diabetes Associated Antibodies\n\nExclusion Criteria:\n\n* Subjects on antibiotics, proton pump inhibitors, aspirin, non-steroidal anti-inflammatory drugs, alcohol intake within 48 hours, a bowel preparation with 4 weeks of the studies, and smokers\n* Subjects will be asked not to take any probiotics in the week before testing.\n* Any known intestinal inflammation such as Gastroesophageal Reflux Disease (GERD), eosinophilic esophagitis, and inflammatory bowel disease.\n* Prior gastrointestinal surgery (other than appendectomy)\n* Ongoing use of antiplatelet agents or anticoagulants.\n* Diabetic patients should not have a prior history of or family history of Celiac Disease (CD).\n* Subjects unable to provide informed consent\n* The presence of any medical or psychological condition that could interfere with the safe performance of the upper endoscopy.\n* Females cannot be pregnant\n\nFor the Healthy Control Cohort:\n\nInclusion Criteria:\n\n\\- Healthy subjects\n\nExclusion Criteria:\n\n* Controls should not have a family history of DM or CD\n* Subjects on antibiotics, proton pump inhibitors, aspirin, non-steroidal anti-inflammatory drugs, alcohol intake within 48 hours, a bowel preparation with 4 weeks of the studies, and smokers\n* Subjects will be asked not to take any probiotics in the week before testing.\n* Any known intestinal inflammation such as Gastroesophageal Reflux Disease (GERD), eosinophilic esophagitis, and inflammatory bowel disease.\n* Prior gastrointestinal surgery (other than appendectomy)\n* Ongoing use of antiplatelet agents or anticoagulants.\n* Subjects unable to provide informed consent\n* The presence of any medical or psychological condition that could interfere with the safe performance of the upper endoscopy.\n* Females cannot be pregnant'}, 'identificationModule': {'nctId': 'NCT01940835', 'briefTitle': 'Role of Intestinal Inflammation in the Pathogenesis of Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Role of Intestinal Inflammation in the Pathogenesis of Type 1 Diabetes', 'orgStudyIdInfo': {'id': '12-003972'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Type 1 Diabetes', 'description': 'Subjects will have an upper endoscopy with small bowel biopsies and brushings. Blood will be collected for serum, DNA, and peripheral blood mononuclear cells (PBMC). Stool samples will be collected at baseline for future microbiome and virome studies.', 'interventionNames': ['Procedure: Upper endoscopy with small bowel biopsies and brushings.', 'Other: Blood draw', 'Other: Stool sample']}, {'label': 'Healthy Control Group', 'description': 'Subjects will have an upper endoscopy with small bowel biopsies and brushings. Blood will be collected for serum, DNA, and peripheral blood mononuclear cells (PBMC). Stool samples will be collected at baseline for future microbiome and virome studies.', 'interventionNames': ['Procedure: Upper endoscopy with small bowel biopsies and brushings.', 'Other: Blood draw', 'Other: Stool sample']}], 'interventions': [{'name': 'Upper endoscopy with small bowel biopsies and brushings.', 'type': 'PROCEDURE', 'armGroupLabels': ['Healthy Control Group', 'Type 1 Diabetes']}, {'name': 'Blood draw', 'type': 'OTHER', 'description': 'Blood will be collected for serum, DNA, and peripheral blood mononuclear cells (PBMC).', 'armGroupLabels': ['Healthy Control Group', 'Type 1 Diabetes']}, {'name': 'Stool sample', 'type': 'OTHER', 'description': 'Stool samples will be collected at baseline for future microbiome and virome studies.', 'armGroupLabels': ['Healthy Control Group', 'Type 1 Diabetes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Joseph Murray, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Juvenile Diabetes Research Foundation', 'class': 'OTHER'}, {'name': 'University of Chicago', 'class': 'OTHER'}, {'name': 'Harvard University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Joseph A. Murray, M.D.', 'investigatorAffiliation': 'Mayo Clinic'}}}}