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| Name | Class |
|---|---|
| Juvenile Diabetes Research Foundation | OTHER |
| University of Chicago | OTHER |
| Harvard University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Type 1 Diabetes | 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. |
| |
| Healthy Control Group | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Upper endoscopy with small bowel biopsies and brushings. | Procedure |
| ||
| Blood draw |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Interleukin 15 (IL-15) Expression | baseline, 3 months |
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For the Diabetes Cohort:
Inclusion Criteria:
Exclusion Criteria:
For the Healthy Control Cohort:
Inclusion Criteria:
- Healthy subjects
Exclusion Criteria:
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Type 1 Diabetes, diagnosed within 6 months
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Murray, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D005773 | Gastroscopy |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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Serum, DNA, RNA extraction, brush biopsies from duodenal mucosa, biopsies of small intestine, stool samples
| Other |
Blood will be collected for serum, DNA, and peripheral blood mononuclear cells (PBMC). |
|
| Stool sample | Other | Stool samples will be collected at baseline for future microbiome and virome studies. |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D011677 | Punctures |
| D008919 | Investigative Techniques |