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Person working on the trial left
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The purpose of the study is to determine the characteristics of patients with diabetes and sarcoidosis and to compare them with those of patients with diabetes and no sarcoidosis. The investigators will approach these aims by measuring hemoglobin A1c, C peptide, insulin levels, and 2-hour glucose tolerance test results on the study population as well as collecting clinical data from records. Three groups of patients will be identified from pulmonary and endocrinology clinics at the University of Alabama at Birmingham. The first group will have a diagnosis of sarcoidosis without diabetes, the second group will have a diagnosis of both sarcoidosis and diabetes, and the third group will have a diagnosis of diabetes without sarcoidosis. Sample size is not pre-determined, but investigators anticipate this number to be less than 100. These patients will be asked in person during an office visit to join the study. For each patient who agrees to join, at a clinic visit, investigators will review and sign consent. Following the visit or at a time convenient for each patient, study subjects will undergo a fasting plasma venous sample collection for a hemoglobin A1c, C peptide, insulin level and perform a 2-hour oral glucose tolerance test. The degree of glucose intolerance and prevalence of diabetes will be analyzed and compared between the groups and to historical published control data via T test comparisons. At a later separate visit, patients recruited will undergo ultrasound of the pancreas to assess pancreatic size and morphology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sarcoidosis Patients | Patients referred to UAB Pulmonology who are diagnosed with sarcoidosis. |
| |
| Diabetes Patients | Patients followed by UAB Endocrinology with diabetes mellitus. |
| |
| Sarcoidosis and Diabetes patients | Patients followed by UAB Pulmonary and/or UAB Endocrinology with both sarcoidosis and diabetes mellitus. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venous blood sample | Diagnostic Test | Venous blood samples will be obtained for hemoglobin A1c, C peptide, insulin level, and 2-hour fasting glucose tolerance test. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in glucose during oral glucose tolerance test (oGTT) | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change in C peptide over oGTT | Baseline | |
| Change in insulin response oGTT | Baseline | |
| Hemoglobin A1c (HbA1c) |
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Inclusion Criteria:
Exclusion Criteria:
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One group will consist of patients referred to or followed at UAB pulmonary clinic with an established diagnosis of sarcoidosis without diabetes mellitus. A second group will consist of patients referred to or followed at UAB pulmonary and/or endocrinology clinic with diagnoses of both sarcoidosis and diabetes mellitus. A third group will consist of patients referred to or followed at UAB endocrinology clinic with a diagnosis of diabetes mellitus without sarcoidosis.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States |
All collected individual participant data (IPD)
starting 1 month after publication
IPD will be shared with future participating researchers who are not yet identified (future fellow physicians).
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| ID | Term |
|---|---|
| D012507 | Sarcoidosis |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006968 | Hypersensitivity, Delayed |
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| Ultrasound of pancreas | Diagnostic Test | Ultrasound of pancreas will be obtained on all study participants. |
|
| Baseline |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |