Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005479
Status:
COMPLETED
Last Update Posted:
2015-12-28
First Post:
2000-05-25
Brief Title:
Diabetes Lipoproteins and Accelerated Vascular Disease
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
Measures of Postprandial Lipoproteins Are Not Associated With Coronary Artery Disease in Patients With Type 2 Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2015-12
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 better understand the excess cardiovascular disease associated with diabetes mellitus
Detailed Description:
BACKGROUND
Diabetes mellitus is associated with a 2-4 fold increase in risk for atherosclerotic cardiovascular disease Atherosclerotic cardiovascular disease particularly coronary artery disease is the leading cause of death in diabetics The study was a subproject within a program project grant with Henry Ginsberg as principal investigator The program project was part of an institute-initiated study on The Etiology of Excess Cardiovascular Disease in Diabetes Mellitus The initiative originated after discussions between NHLBI and the Juvenile Diabetes Foundation International JDFI The Request for Applications RFA was originally issued in October 1994 and resulted in the award of one grant The RFA was reissued in December 1995 and resulted in the awarding of five program project grants the one under discussion among them
DESIGN NARRATIVE
The study subproject 3 within a program project grant was entitled Atherogenic Triglyceride Rich Lipoproteins in Diabetes The subproject examined the atherogenicity of hypertriglyceridemia in subjects with non-insulin dependent diabetes mellitus NIDDM Subproject 3 tested hypotheses concerning the impact of the size and number of triglyceride-rich lipoproteins TGRL on risk for atherosclerotic cardiovascular disease ASCVD in several human populations A case-control study of diabetics with or without coronary artery disease determined if TGRL size and number differed between the groups In this study Whites Blacks and Hispanics with documented coronary artery disease or with less than 50 percent coronary stenosis by angiography were recruited The hypothesis was tested that increased apoB in small TGRL was associated with coronary artery disease Fasting and postprandial blood samples were obtained for measurement of TGRL apoB level TGRL TGapoB ratio the amount of apoB in apoE-rich TGRL and retinyl palmitate clearance Allelic differences in the apoB apoE LPL and apoCIII genes were examined for effects on the size and number of TGRL specific hypotheses were tested regarding the impact of these alleles
TGRL size and number were also compared in diabetics with and without carotid atherosclerosis in the Atherosclerosis Risk in Communities ARIC study in Sioux and Pima Indian tribes that differed in ASCVD rates and in Blacks Whites and Hispanics with a range of insulin levels and insulin resistance in the Insulin Resistance and Atherosclerosis Study IRAS These studies served both to confirm findings in the case-control study and to provide the opportunity to investigate diverse populations The collaboration with IRAS allowed determination of the effects of insulin resistance and insulin secretory capacity on TGRL size and number Finally experiments with cultured endothelial cells were performed to determine if small TGRL could cause endothelial dysfunction PMI-1 and VCAM-1 were markers of TGRL effects In the case-control study plasma PMI and VCAM-1 were measured to examine their relationship to coronary artery disease and to TGRL size and number
Dollars awarded were estimated based on the CRISP assignment of 173249 dollars in FY 1996 for Subproject 3 This was approximately 25 percent of the total dollars awarded and was used to estimated committed dollars
Diabetes mellitus is associated with a 2-4 fold increase in risk for atherosclerotic cardiovascular disease Atherosclerotic cardiovascular disease particularly coronary artery disease is the leading cause of death in diabetics The study was a subproject within a program project grant with Henry Ginsberg as principal investigator The program project was part of an institute-initiated study on The Etiology of Excess Cardiovascular Disease in Diabetes Mellitus The initiative originated after discussions between NHLBI and the Juvenile Diabetes Foundation International JDFI The Request for Applications RFA was originally issued in October 1994 and resulted in the award of one grant The RFA was reissued in December 1995 and resulted in the awarding of five program project grants the one under discussion among them
DESIGN NARRATIVE
The study subproject 3 within a program project grant was entitled Atherogenic Triglyceride Rich Lipoproteins in Diabetes The subproject examined the atherogenicity of hypertriglyceridemia in subjects with non-insulin dependent diabetes mellitus NIDDM Subproject 3 tested hypotheses concerning the impact of the size and number of triglyceride-rich lipoproteins TGRL on risk for atherosclerotic cardiovascular disease ASCVD in several human populations A case-control study of diabetics with or without coronary artery disease determined if TGRL size and number differed between the groups In this study Whites Blacks and Hispanics with documented coronary artery disease or with less than 50 percent coronary stenosis by angiography were recruited The hypothesis was tested that increased apoB in small TGRL was associated with coronary artery disease Fasting and postprandial blood samples were obtained for measurement of TGRL apoB level TGRL TGapoB ratio the amount of apoB in apoE-rich TGRL and retinyl palmitate clearance Allelic differences in the apoB apoE LPL and apoCIII genes were examined for effects on the size and number of TGRL specific hypotheses were tested regarding the impact of these alleles
TGRL size and number were also compared in diabetics with and without carotid atherosclerosis in the Atherosclerosis Risk in Communities ARIC study in Sioux and Pima Indian tribes that differed in ASCVD rates and in Blacks Whites and Hispanics with a range of insulin levels and insulin resistance in the Insulin Resistance and Atherosclerosis Study IRAS These studies served both to confirm findings in the case-control study and to provide the opportunity to investigate diverse populations The collaboration with IRAS allowed determination of the effects of insulin resistance and insulin secretory capacity on TGRL size and number Finally experiments with cultured endothelial cells were performed to determine if small TGRL could cause endothelial dysfunction PMI-1 and VCAM-1 were markers of TGRL effects In the case-control study plasma PMI and VCAM-1 were measured to examine their relationship to coronary artery disease and to TGRL size and number
Dollars awarded were estimated based on the CRISP assignment of 173249 dollars in FY 1996 for Subproject 3 This was approximately 25 percent of the total dollars awarded and was used to estimated committed dollars
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 |
|---|---|---|---|
| P01HL057217 | NIH | None | httpsreporternihgovquickSearchP01HL057217 |