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| ID | Type | Description | Link |
|---|---|---|---|
| P30GM103341 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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This proposal seeks to assess the impact of 24 weeks of metformin on non-calcified plaques and calcified plaques assessed by coronary CT angiography, and on whether these changes can be explained by metformin-induced phenotypic and secretory changes of monocytes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin Treatment Arm | Active Comparator | 500 mg metformin Extended Release tablets - one tablet daily increased at 4 weeks to 2 tablets (1000 mg) daily. |
|
| Observational Arm | No Intervention | Observation only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| metformin extended release | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Coronary plaques by CT angiography | change in total numbers of atherosclerotic plaques detected in the coronary arteries | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Monocyte subsets by multiparametric flow cytometry | change in numbers (cells/microliter of blood) of each monocyte subset (classical, intermediate, non-classical and transitional subsets) | 24 weeks |
| Monocyte secretory function by intracellular cytokine staining release assay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nancy Hanks, RN | Contact | 808 692-1336 | nhanks@hawaii.edu | |
| Debra Ogata-Arakaki, RN | Contact | 808 692-1332 | ogataara@hawaii.edu |
| Name | Affiliation | Role |
|---|---|---|
| Cecilia M Shikuma, MD | University of Hawaii | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hawaii Center for AIDS | Recruiting | Honolulu | Hawaii | 96813 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 24, 2018 | |
| Reset | Feb 20, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 24, 2018 | Feb 20, 2018 |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Change in percent of monocytes secreting cytokine TNFalpha, percent secreting cytokine IL-6 and percent secreting cytokine IL-1beta |
| 24 weeks |
| Sub-types of coronary plaques by CT angiography | Change in numbers of non-calcified atherosclerotic plaques detected in the coronary arteries; change in numbers of mixed plaques; change in numbers of calcified coronary plaques | 24 weeks |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |