Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00021944
Status:
COMPLETED
Last Update Posted:
2016-07-29
First Post:
2001-08-10
Brief Title:
Non-Traditional Cardiovascular Risk Factors in Type 2 Diabetes Mellitus - Ancillary to VA Study of Glycemic Control
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2008-01
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:
To test whether novel cardiovascular risk factors are related to the presence and development of atherosclerosis and macrovascular events in Type 2 diabetes mellitus and to determine whether intensive glucose lowering therapy will reduce the levels of these cardiovascular risk factors
Detailed Description:
BACKGROUND
A predominant consequence of Type 2 diabetes mellitus is accelerated development of atherosclerosis related conditions Conventional cardiovascular risk factors only explain a portion of the excess risk for atherosclerosis in this population This ancillary study uses the study population and framework of the V A Cooperative study of Glycemic Control and Complications in DM 2 The Cooperative study is a prospective two-arm randomized controlled multicenter trial to assess the effects of tight glycemic control achieved through intensification of treatment on clinical macrovascular and microvascular complications in patients with Type 2 diabetes mellitus who are in poor glycemic control despite pharmacologic therapy Cooperative study subjects from multiple sites 340 subjects are participating in the trial
The study is in response to an initiative Ancillary Studies in Heart Lung and Blood Disease Trials released by the National Heart Lung and Blood Institute in June 2000
DESIGN NARRATIVE
This ancillary study examines non traditional risk factors which may contribute to accelerated cardiovascular disease in Type 2 diabetes and the effects of intensive versus standard glycemic management on these risk factors Specific short-term primary aims include determining the cross-sectional relationship between baseline levels and the presence of atherosclerosis as measured by electron beam computed tomography assessment of coronary artery CAC and abdominal aortic calcium AAC and the prevalence of clinical macrovascular disease An estimated 340 Cooperative study subjects from multiple sites will be asked to participate in this additional study At their baseline visit subjects will have additional blood and urine collected for a VLDL IDL and LDL subfractions b measures of in vivo oxidative stress oxidized-phospholipids on plasma LDL autoantibodies to epitopes of oxidized LDL F2-isoprostane levels c AGE-LDL levels and d markers of endothelial activationinjury PAI-1 VCAM-1 and ICAM-1 and inflammation C-reactive protein and fibrinogen Subjects will also have CAC and AAC determined After enrollment in the study participants will have measurements of cardiovascular risk factors repeated at six months Primary and secondary macrovascular endpoints will be identical to those defined in the VA Cooperative study Primary myocardial infarction cardiovascular death stroke congestive heart failure invasive vascular therapy coronary or peripheral and amputation due to ischemic gangrene Secondary angina pectoris transient ischemic attacks and peripheral artery disease Statistical methods depending on the specific aim will include categorical age and sex adjusted analyses t-tests and multiple regression models Long-term aims will include evaluating the prospective relationship of these novel cardiovascular risk factors to the progression of atherosclerosis and the development of macrovascular disease in this same population
A predominant consequence of Type 2 diabetes mellitus is accelerated development of atherosclerosis related conditions Conventional cardiovascular risk factors only explain a portion of the excess risk for atherosclerosis in this population This ancillary study uses the study population and framework of the V A Cooperative study of Glycemic Control and Complications in DM 2 The Cooperative study is a prospective two-arm randomized controlled multicenter trial to assess the effects of tight glycemic control achieved through intensification of treatment on clinical macrovascular and microvascular complications in patients with Type 2 diabetes mellitus who are in poor glycemic control despite pharmacologic therapy Cooperative study subjects from multiple sites 340 subjects are participating in the trial
The study is in response to an initiative Ancillary Studies in Heart Lung and Blood Disease Trials released by the National Heart Lung and Blood Institute in June 2000
DESIGN NARRATIVE
This ancillary study examines non traditional risk factors which may contribute to accelerated cardiovascular disease in Type 2 diabetes and the effects of intensive versus standard glycemic management on these risk factors Specific short-term primary aims include determining the cross-sectional relationship between baseline levels and the presence of atherosclerosis as measured by electron beam computed tomography assessment of coronary artery CAC and abdominal aortic calcium AAC and the prevalence of clinical macrovascular disease An estimated 340 Cooperative study subjects from multiple sites will be asked to participate in this additional study At their baseline visit subjects will have additional blood and urine collected for a VLDL IDL and LDL subfractions b measures of in vivo oxidative stress oxidized-phospholipids on plasma LDL autoantibodies to epitopes of oxidized LDL F2-isoprostane levels c AGE-LDL levels and d markers of endothelial activationinjury PAI-1 VCAM-1 and ICAM-1 and inflammation C-reactive protein and fibrinogen Subjects will also have CAC and AAC determined After enrollment in the study participants will have measurements of cardiovascular risk factors repeated at six months Primary and secondary macrovascular endpoints will be identical to those defined in the VA Cooperative study Primary myocardial infarction cardiovascular death stroke congestive heart failure invasive vascular therapy coronary or peripheral and amputation due to ischemic gangrene Secondary angina pectoris transient ischemic attacks and peripheral artery disease Statistical methods depending on the specific aim will include categorical age and sex adjusted analyses t-tests and multiple regression models Long-term aims will include evaluating the prospective relationship of these novel cardiovascular risk factors to the progression of atherosclerosis and the development of macrovascular disease in this same population
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL067690 | NIH | None | httpsreporternihgovquickSearchR01HL067690 |