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The purpose of this study is to assess the levels of autoimmune markers of diabetes in those with a type 2 diabetes diagnosis.
Autoimmune markers can appear when the body uses its natural defense system to mistakenly attack the patient's own cells because it cannot tell the difference between the patient and foreign cells. The study investigators want to determine if there are any differences in these marker levels when comparing patients who are managed by their primary care provider and patients managed by endocrinology. Patients will be asked to come in for a blood draw. This sample will be used for autoimmune antibody testing. An antibody is a protein in the blood that is made to find and respond to a specific antigen. An antigen is something that triggers the body to have an immune response. Patient participation in the research study will last for the duration of one visit to the clinic for informed consent and a blood draw.
The clinical implications of detecting this type of diabetes can be profound, as it can identify patients who are at risk of becoming insulin dependent in the near future, and therefore may require a change in diabetes management to avoid adverse outcomes. In addition, identifying these patients may also open up the door for treatments directed at stopping the complete autoimmune destruction of insulin producing cells, potentially delaying or avoiding the need for insulin dependency.
The study team presumes that autoimmune markers of diabetes will be detected in patients with a diagnosis of type 2 diabetes and the prevalence of these markers will be higher among patients managed by endocrinology. The population of patients found to have detectable autoimmune markers of diabetes will differ from the population of patients without these markers. The population of patients managed by endocrinology that are found to have detectable autoimmune markers of diabetes will differ from the population of patients managed by primary care. The population of patients with more than 1 autoimmune antibody are more likely to require insulin therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients Seen by their Endocrinologist | Patients whose diabetes is managed by their Endocrinologist |
| |
| Patients Seen by their Primary Care Provider | Patients whose diabetes is managed by their Primary Care Provider |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autoimmune Antibody Assays | Diagnostic Test | GAD-65, Islet cell-Ab, IA-2 Ab, anti-insulin Ab, and ZnTn8 Ab |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of autoimmune antibodies in patients with Type 2 Diabetes | Percentage of subjects with T2D and detectable autoimmune antibodies calculated as the percentage of subjects that test positive for at least one of the autoimmune antibodies | One-time blood draw at consent/screening |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of autoimmune antibodies in patients with T2D managed by endocrinology | Percentage of subjects whose diabetes is managed by an endocrinologist with T2D and detectable autoimmune antibodies calculated as the percentage of subjects that test positive for at least one of the autoimmune antibodies | One-time blood draw at consent/screening |
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Inclusion Criteria:
Exclusion Criteria:
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Participants will be recruited from community hospital either coming in to see their primary care physician or endocrinologist.
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Pantalone, DO | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Twinsburg Family Health & Surgery Center | Twinsburg | Ohio | 44087 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Prevalence of autoimmune antibodies in patients with T2D managed by primary care | Percentage of subjects whose diabetes is managed by a primacy care physician with T2D and detectable autoimmune antibodies calculated as the percentage of subjects that test positive for at least one of the autoimmune antibodies | One-time blood draw at consent/screening |
| D004700 | Endocrine System Diseases |