A Suspected Association Between Sarcoidosis and Development of Diabetes Mellitus
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Sarcoidosis Patients Patients referred to UAB Pulmonology who are diagnosed with sarcoidosis. |
Diagnostic Test: Venous blood sample
Venous blood samples will be obtained for hemoglobin A1c, C peptide, insulin level, and 2-hour fasting glucose tolerance test.
Diagnostic Test: Ultrasound of pancreas
Ultrasound of pancreas will be obtained on all study participants.
|
| Diabetes Patients Patients followed by UAB Endocrinology with diabetes mellitus. |
Diagnostic Test: Venous blood sample
Venous blood samples will be obtained for hemoglobin A1c, C peptide, insulin level, and 2-hour fasting glucose tolerance test.
Diagnostic Test: Ultrasound of pancreas
Ultrasound of pancreas will be obtained on all study participants.
|
| Sarcoidosis and Diabetes patients Patients followed by UAB Pulmonary and/or UAB Endocrinology with both sarcoidosis and diabetes mellitus. |
Diagnostic Test: Venous blood sample
Venous blood samples will be obtained for hemoglobin A1c, C peptide, insulin level, and 2-hour fasting glucose tolerance test.
Diagnostic Test: Ultrasound of pancreas
Ultrasound of pancreas will be obtained on all study participants.
|
Outcome Measures
Primary Outcome Measures
- Change in glucose during oral glucose tolerance test (oGTT) [Baseline]
Secondary Outcome Measures
- Change in C peptide over oGTT [Baseline]
- Change in insulin response oGTT [Baseline]
- Hemoglobin A1c (HbA1c) [Baseline]
Eligibility Criteria
Criteria
Inclusion Criteria:
- Any adult patient referred to or followed in UAB pulmonary clinic with an established diagnosis of sarcoidosis. Any adult patient followed in UAB endocrinology clinic with a diagnosis of diabetes mellitus (excluding type 1 diabetes).
Exclusion Criteria:
- Type 1 diabetes and/or chronic use of corticosteroids.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama at Birmingham | Birmingham | Alabama | United States | 35233 |
Sponsors and Collaborators
- University of Alabama at Birmingham
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB-300000289