Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00256646
Status:
COMPLETED
Last Update Posted:
2014-05-23
First Post:
2005-11-17
Brief Title:
Markers and Mechanisms of Vascular Disease in Type II Diabetes
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
CSP 465D - Markers And Mechanisms of Vascular Disease in Type II Diabetes
Status:
COMPLETED
Status Verified Date:
2014-05
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:
OBJECTIVES Vascular Disease is the leading cause of complications and death in patients with diabetes Risk markers and underlying mechanisms have not been fully elucidated and may differ from those in non-diabetic individuals The unifying theme for the Program Project is that hyperglycemia and insulin resistance alter a number of biological processes which interact in vicious cycles to accelerate atherogenesis and are consequently major underlying risk factors for vascular disease The overall objectives are to define these unique processes and to elucidate underlying biochemical metabolic and genetic determinants of vascular disease complications in diabetes
RESEARCH PLAN Over the past 4 years we have collaborated with the DCCTEDIC Study Group and have made novel observations regarding vascular disease pathogenesis in Type 1 Diabetes This work has focused our studies on specific pathogenic processes We will now study a Type 2 Diabetes cohort from the VA Cooperative Study Glycemic Control and the Complications of Diabetes Type 2 with high vascular disease event rates These collaborations provide a unique opportunity to address the pathogenesis of accelerated atherogenesis in the two main types of diabetes and will greatly augment the scientific knowledge that will be gained in the conduct of these world-class prospective trials
METHODS The Program Project has 4 projects and 3 cores Project 1 will assess lipoproteins glycoxidative stress and inflammation as risk factors in studies involving Type 2 Diabetes patients and cultured cell systems Based on preliminary data from our initial studies Type 1 patients changes in the NMR lipoprotein subclass profile will be emphasized
Project 2 will elucidate interactions between inflammation modifications of lipoproteins and autoimmunity in vascular disease risk These novel concepts are also based upon exciting preliminary data pertaining to LDL-antibody complexes
Project 3 will pursue interesting preliminary data and define the role of the kallikrein-kinin system in vascular disease complications with effects on mitogenesis and matrix production
Project 4 will assess the role of the Insulin Resistance Syndrome and novel factors secreted from adipocytes in the pathophysiology of biochemical risk factors and cardiovascular complications
Cores include an Administrative Core a Biostatistics and Epidemiology Core which will link with the trials data coordinating centers and Molecular and Statistical Genetics Core Investigators will work in close collaboration with the VA Executive Committee Study Centers the Hines Coordinating Center and some of the other ancillary studies All data analysis involving clinical outcomes will be performed at the Hines Coordinating Center
There is true synergism among the projects at both scientific and logistical levels The Program Project design allows for interactions among multidisciplinary investigators studying the same cohort which will define how multiple pathological processes interact at the level of the arterial wall to promote atherosclerosis
RESEARCH PLAN Over the past 4 years we have collaborated with the DCCTEDIC Study Group and have made novel observations regarding vascular disease pathogenesis in Type 1 Diabetes This work has focused our studies on specific pathogenic processes We will now study a Type 2 Diabetes cohort from the VA Cooperative Study Glycemic Control and the Complications of Diabetes Type 2 with high vascular disease event rates These collaborations provide a unique opportunity to address the pathogenesis of accelerated atherogenesis in the two main types of diabetes and will greatly augment the scientific knowledge that will be gained in the conduct of these world-class prospective trials
METHODS The Program Project has 4 projects and 3 cores Project 1 will assess lipoproteins glycoxidative stress and inflammation as risk factors in studies involving Type 2 Diabetes patients and cultured cell systems Based on preliminary data from our initial studies Type 1 patients changes in the NMR lipoprotein subclass profile will be emphasized
Project 2 will elucidate interactions between inflammation modifications of lipoproteins and autoimmunity in vascular disease risk These novel concepts are also based upon exciting preliminary data pertaining to LDL-antibody complexes
Project 3 will pursue interesting preliminary data and define the role of the kallikrein-kinin system in vascular disease complications with effects on mitogenesis and matrix production
Project 4 will assess the role of the Insulin Resistance Syndrome and novel factors secreted from adipocytes in the pathophysiology of biochemical risk factors and cardiovascular complications
Cores include an Administrative Core a Biostatistics and Epidemiology Core which will link with the trials data coordinating centers and Molecular and Statistical Genetics Core Investigators will work in close collaboration with the VA Executive Committee Study Centers the Hines Coordinating Center and some of the other ancillary studies All data analysis involving clinical outcomes will be performed at the Hines Coordinating Center
There is true synergism among the projects at both scientific and logistical levels The Program Project design allows for interactions among multidisciplinary investigators studying the same cohort which will define how multiple pathological processes interact at the level of the arterial wall to promote atherosclerosis
Detailed Description:
Primary Hypothesis
Secondary Hypotheses
Primary Outcomes
Study Abstract
OBJECTIVES Vascular Disease is the leading cause of complications and death in patients with diabetes Risk markers and underlying mechanisms have not been fully elucidated and may differ from those in non-diabetic individuals The unifying theme for the Program Project is that hyperglycemia and insulin resistance alter a number of biological processes which interact in vicious cycles to accelerate atherogenesis and are consequently major underlying risk factors for vascular disease The overall objectives are to define these unique processes and to elucidate underlying biochemical metabolic and genetic determinants of vascular disease complications in diabetes
RESEARCH PLAN Over the past 4 years we have collaborated with the DCCTEDIC Study Group and have made novel observations regarding vascular disease pathogenesis in Type 1 Diabetes This work has focused our studies on specific pathogenic processes We will now study a Type 2 Diabetes cohort from the VA Cooperative Study Glycemic Control and the Complications of Diabetes Type 2 with high vascular disease event rates These collaborations provide a unique opportunity to address the pathogenesis of accelerated atherogenesis in the two main types of diabetes and will greatly augment the scientific knowledge that will be gained in the conduct of these world-class prospective trials
METHODS The Program Project has 4 projects and 3 cores Project 1 will assess lipoproteins glycoxidative stress and inflammation as risk factors in studies involving Type 2 Diabetes patients and cultured cell systems Based on preliminary data from our initial studies Type 1 patients changes in the NMR lipoprotein subclass profile will be emphasized
Project 2 will elucidate interactions between inflammation modifications of lipoproteins and autoimmunity in vascular disease risk These novel concepts are also based upon exciting preliminary data pertaining to LDL-antibody complexes
Project 3 will pursue interesting preliminary data and define the role of the kallikrein-kinin system in vascular disease complications with effects on mitogenesis and matrix production
Project 4 will assess the role of the Insulin Resistance Syndrome and novel factors secreted from adipocytes in the pathophysiology of biochemical risk factors and cardiovascular complications
Cores include an Administrative Core a Biostatistics and Epidemiology Core which will link with the trials data coordinating centers and Molecular and Statistical Genetics Core Investigators will work in close collaboration with the VA Executive Committee Study Centers the Hines Coordinating Center and some of the other ancillary studies All data analysis involving clinical outcomes will be performed at the Hines Coordinating Center
There is true synergism among the projects at both scientific and logistical levels The Program Project design allows for interactions among multidisciplinary investigators studying the same cohort which will define how multiple pathological processes interact at the level of the arterial wall to promote atherosclerosis
Main Manuscript
There is no independent data for this study it was part of a larger study Therefore there will be no results for this recordstudy
Secondary Hypotheses
Primary Outcomes
Study Abstract
OBJECTIVES Vascular Disease is the leading cause of complications and death in patients with diabetes Risk markers and underlying mechanisms have not been fully elucidated and may differ from those in non-diabetic individuals The unifying theme for the Program Project is that hyperglycemia and insulin resistance alter a number of biological processes which interact in vicious cycles to accelerate atherogenesis and are consequently major underlying risk factors for vascular disease The overall objectives are to define these unique processes and to elucidate underlying biochemical metabolic and genetic determinants of vascular disease complications in diabetes
RESEARCH PLAN Over the past 4 years we have collaborated with the DCCTEDIC Study Group and have made novel observations regarding vascular disease pathogenesis in Type 1 Diabetes This work has focused our studies on specific pathogenic processes We will now study a Type 2 Diabetes cohort from the VA Cooperative Study Glycemic Control and the Complications of Diabetes Type 2 with high vascular disease event rates These collaborations provide a unique opportunity to address the pathogenesis of accelerated atherogenesis in the two main types of diabetes and will greatly augment the scientific knowledge that will be gained in the conduct of these world-class prospective trials
METHODS The Program Project has 4 projects and 3 cores Project 1 will assess lipoproteins glycoxidative stress and inflammation as risk factors in studies involving Type 2 Diabetes patients and cultured cell systems Based on preliminary data from our initial studies Type 1 patients changes in the NMR lipoprotein subclass profile will be emphasized
Project 2 will elucidate interactions between inflammation modifications of lipoproteins and autoimmunity in vascular disease risk These novel concepts are also based upon exciting preliminary data pertaining to LDL-antibody complexes
Project 3 will pursue interesting preliminary data and define the role of the kallikrein-kinin system in vascular disease complications with effects on mitogenesis and matrix production
Project 4 will assess the role of the Insulin Resistance Syndrome and novel factors secreted from adipocytes in the pathophysiology of biochemical risk factors and cardiovascular complications
Cores include an Administrative Core a Biostatistics and Epidemiology Core which will link with the trials data coordinating centers and Molecular and Statistical Genetics Core Investigators will work in close collaboration with the VA Executive Committee Study Centers the Hines Coordinating Center and some of the other ancillary studies All data analysis involving clinical outcomes will be performed at the Hines Coordinating Center
There is true synergism among the projects at both scientific and logistical levels The Program Project design allows for interactions among multidisciplinary investigators studying the same cohort which will define how multiple pathological processes interact at the level of the arterial wall to promote atherosclerosis
Main Manuscript
There is no independent data for this study it was part of a larger study Therefore there will be no results for this recordstudy
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