Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00441844
Status:
COMPLETED
Last Update Posted:
2007-03-01
First Post:
2007-02-27
Brief Title:
Monocyte Function and Inflammation in Type 1 Diabetes and Its Modulation
Sponsor:
University of California Davis
Organization:
University of California Davis
Study Overview
Official Title:
Phase 2 Study Examining the Effect of Simvastatin vs Placebo on Monocyte Function and Inflammation in Patients With Type 1 Diabetes
Status:
COMPLETED
Status Verified Date:
2007-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Type I diabetes T1DM is associated with an increased risk of vascular complications While the precise mechanisms by which diabetes accelerates atherosclerosis has not been elucidated several lines of evidence point to the role of increased inflammation in the pathogenesis of these vasculopathies The monocyte-macrophage is a pivotal cell in atherogenesis and is readily accessible for study However there is scanty data on monocyte function and inflammation in T1DM Simvastatin a HMG-CoA reductase inhibitor has recently been shown to reduce cardiovascular events in diabetic patients T1DM and T2DM in the Heart Protection Study Recent studies demonstrate that simvastatin decreased C-reactive protein and decreased pro-atherogenic activity of monocytes in non-diabetic subjects However there is a paucity of data on the effect of simvastatin on inflammation and monocyte function in Type 1 diabetes
Thus the purpose of this study is Aim 1 to assess biomarkers of inflammation in T1DM compared to matched controls n50group Aim 2 Also we will assess the effect of simvastatin 20mgday therapy on inflammation and monocyte function in T1DM in a randomized placebo-controlled double blind trial
Thus the purpose of this study is Aim 1 to assess biomarkers of inflammation in T1DM compared to matched controls n50group Aim 2 Also we will assess the effect of simvastatin 20mgday therapy on inflammation and monocyte function in T1DM in a randomized placebo-controlled double blind trial
Detailed Description:
Type I diabetes T1DM is associated with an increased risk of vascular complications While the precise mechanisms by which diabetes accelerates atherosclerosis has not been elucidated several lines of evidence point to the role of increased inflammation in the pathogenesis of these vasculopathies The monocyte-macrophage is a pivotal cell in atherogenesis and is readily accessible for study However there is scanty data on monocyte function and inflammation in T1DM Simvastatin a HMG-CoA reductase inhibitor has recently been shown to reduce cardiovascular events in diabetic patients T1DM and T2DM in the Heart Protection Study Recent studies demonstrate that simvastatin decreased C-reactive protein and decreased pro-atherogenic activity of monocytes in non-diabetic subjects However there is a paucity of data on the effect of simvastatin on inflammation and monocyte function in Type 1 diabetes
Thus the purpose of this study is Aim 1 to assess biomarkers of inflammation in T1DM compared to matched controls n50group Aim 2 Also we will assess the effect of simvastatin 20mgday therapy on inflammation and monocyte function in T1DM in a randomized placebo-controlled double blind trial
At baseline and post-therapy fasting blood will be obtained for routine laboratories including lipid profile glucose glycated hemoglobin free fatty acid levels biomarkers of inflammation high sensitive C-reactive protein plasma soluble cell adhesion molecules sVCAMsICAM sE-selectin and sP-selectin CD40 ligand monocyte pro-atherogenic activity superoxide anion monocyte chemotactic protein-1 interleukin IL-1b IL-6 and tumor necrosis factor-a release adhesion to human aortic endothelium CD40 expression etc and 24-hour urine for microalbumin
Thus the purpose of this study is Aim 1 to assess biomarkers of inflammation in T1DM compared to matched controls n50group Aim 2 Also we will assess the effect of simvastatin 20mgday therapy on inflammation and monocyte function in T1DM in a randomized placebo-controlled double blind trial
At baseline and post-therapy fasting blood will be obtained for routine laboratories including lipid profile glucose glycated hemoglobin free fatty acid levels biomarkers of inflammation high sensitive C-reactive protein plasma soluble cell adhesion molecules sVCAMsICAM sE-selectin and sP-selectin CD40 ligand monocyte pro-atherogenic activity superoxide anion monocyte chemotactic protein-1 interleukin IL-1b IL-6 and tumor necrosis factor-a release adhesion to human aortic endothelium CD40 expression etc and 24-hour urine for microalbumin
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UCD IRB 200210057 | None | None | None |