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| ID | Type | Description | Link |
|---|---|---|---|
| 09-DK-0140 |
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All analysis with identifiable specimens/data is complete or site has no identifiers linked to the specimens/data
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Background:
Objectives:
Eligibility:
Design:
Individuals with known or suspected autoimmune mediated diabetes, or healthy individuals at risk for developing the disease, will be evaluated at the NIH Clinical Center. Studies will include characterizing the disease s clinical and laboratory features, observing the natural history of the disease and its complications, evaluating responses to standard treatments. Protocol enrollees may be asked to contribute blood and/or urine samples for immunological research studies, and/or for studies designed to find parameters that increase a subject s risk for diabetes and/or its associated complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetes | Individuals who have been diagnosed with or are at risk for developing diabetes |
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| Measure | Description | Time Frame |
|---|---|---|
| Blood glucose level | Blood glucose level within a range appropriate for the patient's condition. | every 3 months |
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-INCLUSION CRITERIA:
i. Clinical diagnosis of diabetes, either type 1 (T1D) or insulin-requiring type 2 (T2D),
ii. Healthy individuals who may be at risk for developing diabetes,
iii. Individuals with suspected immune mediated diabetes,
iv. Willingness of the patient or guardian to give informed consent and assent.
EXCLUSION CRITERIA:
i. Concomitant medical problems which would confound the interpretation studies of the autoimmune beta cell destructive process
ii. Concomitant medical, surgical, or other conditions for which adequate facilities or funds are not available to support their care at the NIH.
iii. Any other co-existing condition/circumstances that would make a subject unsuitable to participate in the study, as deemed by the investigators.
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Individuals who have been diagnosed with or are at risk for developing diabetes
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| Name | Affiliation | Role |
|---|---|---|
| Ranganath Muniyappa, M.D. | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16015359 | Background | Harlan DM, von Herrath M. Immune intervention with anti-CD3 in diabetes. Nat Med. 2005 Jul;11(7):716-8. doi: 10.1038/nm0705-716. No abstract available. | |
| 17259470 | Background | Haines L, Wan KC, Lynn R, Barrett TG, Shield JP. Rising incidence of type 2 diabetes in children in the U.K. Diabetes Care. 2007 May;30(5):1097-101. doi: 10.2337/dc06-1813. Epub 2007 Jan 26. |
| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 16306342 | Background | Palmer JP, Hampe CS, Chiu H, Goel A, Brooks-Worrell BM. Is latent autoimmune diabetes in adults distinct from type 1 diabetes or just type 1 diabetes at an older age? Diabetes. 2005 Dec;54 Suppl 2:S62-7. doi: 10.2337/diabetes.54.suppl_2.s62. |
| 22123298 | Derived | Lo B, Swafford AD, Shafer-Weaver KA, Jerome LF, Rakhlin L, Mathern DR, Callahan CA, Jiang P, Davison LJ, Stevens HE, Lucas CL, White J, von Borstel R, Todd JA, Lenardo MJ. Antibodies against insulin measured by electrochemiluminescence predicts insulitis severity and disease onset in non-obese diabetic mice and can distinguish human type 1 diabetes status. J Transl Med. 2011 Nov 28;9:203. doi: 10.1186/1479-5876-9-203. |
| D004700 | Endocrine System Diseases |
| D007154 | Immune System Diseases |