Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00035750
Status:
COMPLETED
Last Update Posted:
2016-02-01
First Post:
2002-05-04
Brief Title:
Risk Factors for Atherogenesis in Type 1 Diabetes
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2016-01
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 determine risk factors for atherogenesis in Type 1 diabetes
Detailed Description:
BACKGROUND
Individuals with Type 1 diabetes have substantially higher risk for premature atherosclerotic vascular disease ASVD than the general population Risk factors for the development of ASVD have been identified but linking them to initiation of atherosclerosis was not feasible until recently Advances in non-invasive imaging now permit early detection of changes in blood vessel function and structure This imaging provides an opportunity to evaluate risk factors for ASVD and vascular status in a cohort at a critical time for development and early progression of ASVD
DESIGN NARRATIVE
Subjects were enrolled from 1987-1992 and were followed from diabetes diagnosis Standardized protocols for examinations and interviews were implemented and the data base included a valuable longitudinal plasma bank Because incident cases were enrolled information was collected from diagnosis on children adolescents and young adults currently without symptoms of atherosclerosis The existing database was expanded the existing resources were used including the plasma bank and promising new and well established clinical research techniques were incorporated by i measuring plasma lipid levels on stored plasma and on newly collected blood samples ii measuring triglyceride levels on newly collected blood samples iii measuring urinary albumin excretion rates on newly collected specimens already measured from diagnosis to date and iv assessing endothelial function by brachial artery ultrasound v measuring the intima medial thickness IMT of the carotid artery by ultrasound and vi measuring coronary calcium by computed tomography scanning These activities allowed pursuit of the following specific aims 1 to determine the relationship between established risk factors for atherosclerosis and the development of pre-clinical atherosclerosis 2 to determine the relationship between endothelial dysfunction and carotid IMT and 3 to determine the relationship between coronary artery calcification and carotid IMT Such information was critical in directing further efforts toward primary prevention of atherosclerosis in individuals with Type 1 diabetes mellitus
Individuals with Type 1 diabetes have substantially higher risk for premature atherosclerotic vascular disease ASVD than the general population Risk factors for the development of ASVD have been identified but linking them to initiation of atherosclerosis was not feasible until recently Advances in non-invasive imaging now permit early detection of changes in blood vessel function and structure This imaging provides an opportunity to evaluate risk factors for ASVD and vascular status in a cohort at a critical time for development and early progression of ASVD
DESIGN NARRATIVE
Subjects were enrolled from 1987-1992 and were followed from diabetes diagnosis Standardized protocols for examinations and interviews were implemented and the data base included a valuable longitudinal plasma bank Because incident cases were enrolled information was collected from diagnosis on children adolescents and young adults currently without symptoms of atherosclerosis The existing database was expanded the existing resources were used including the plasma bank and promising new and well established clinical research techniques were incorporated by i measuring plasma lipid levels on stored plasma and on newly collected blood samples ii measuring triglyceride levels on newly collected blood samples iii measuring urinary albumin excretion rates on newly collected specimens already measured from diagnosis to date and iv assessing endothelial function by brachial artery ultrasound v measuring the intima medial thickness IMT of the carotid artery by ultrasound and vi measuring coronary calcium by computed tomography scanning These activities allowed pursuit of the following specific aims 1 to determine the relationship between established risk factors for atherosclerosis and the development of pre-clinical atherosclerosis 2 to determine the relationship between endothelial dysfunction and carotid IMT and 3 to determine the relationship between coronary artery calcification and carotid IMT Such information was critical in directing further efforts toward primary prevention of atherosclerosis in individuals with Type 1 diabetes mellitus
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 |
|---|---|---|---|
| R01HL062897 | NIH | None | httpsreporternihgovquickSearchR01HL062897 |