Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00147251
Status:
COMPLETED
Last Update Posted:
2021-07-07
First Post:
2005-09-02
Brief Title:
Stop Atherosclerosis in Native Diabetics Study
Sponsor:
Cynthia West
Organization:
Medstar Health Research Institute
Study Overview
Official Title:
Stop Atherosclerosis in Native Diabetics Study
Status:
COMPLETED
Status Verified Date:
2021-06
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:
SANDS
Brief Summary:
Compared to standard treatment goals achieving lower targets for LDL cholesterol bad cholesterol and blood pressure in people with diabetes will slow the progression of atherosclerosis as measured by carotid artery thickness and reduce clinical cardiovascular events such as heart attacks and strokes This study is a randomized 3-year trial The primary endpoint will be a combination of various measures of the carotid artery which is an easy non-invasive way to detect cardiovascular disease and events such as heart attacks and strokes The study will also look at secondary endpoints such as how well the heart pumps fatprotein and inflammatory markers in the bloodand kidney function The study enrolled 549 American Indian men and women with diabetes 40 years of age and is being conducted in four field centers involving Indian Health ServiceTribal primary care facilities in PhoenixSacaton Arizona Chinle Arizona Rapid CityPine Ridge South Dakota and Lawton Oklahoma with input from American Indian physicians and community members
Detailed Description:
Diabetes incidence is increasing rapidly in the United States Diabetes increases the risk for CVD the major cause of death in diabetic individuals The conventional cardiovascular risk factors of hyperlipidemia and hypertension add to the progression of diabetic vascular disease Appropriate treatment targets for LDL-C and blood pressure in diabetic individuals are currently being debated The Stop Atherosclerosis in Native Diabetics Study is a randomized open label 3-year clinical trial to examine the effects of aggressive LDL-C goal 70 mgdL and BP goal 11575 mm Hg reduction versus the standard goals of 100 mgdL for LDL-C and 13085 mmHg for BP Five hundred forty-nine American Indian men and women age 40 with type 2 diabetes were randomized to one of two groups Lipids and BP are managed using FDA-approved medications in an algorithmic approach The presence and progression of atherosclerosis are evaluated by carotid ultrasonography echocardiography assesses cardiac function The primary endpoint is the composite outcome of change in carotid artery intimal medial thickness and fatalnonfatal cardiovascular events These outcomes are combined by using a ranked analysis for carotid thickness and assigning a worst rank for a cardiovascular event Secondary endpoints include carotid plaque score left ventricular geometry and function serum CRP and safety measures Unique aspects of the study design and analysis plan involve changes during the trial of LDL-C treatment goals for participants with baseline or incident CVD in the conventional group because of changes in the standard of care and the use of a composite outcome Study results will be valuable in understanding the effects of aggressive risk factor reduction on atherosclerosis burden and cardiac function in diabetic individuals in all US populations and will provide evidence for determining optimal LDL-C and BP treatment goals for diabetic patients
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 |
|---|---|---|---|
| Grant 1 U01 HL67031 | OTHER_GRANT | NHLBI | None |