Stop Atherosclerosis in Native Diabetics Study (SANDS) ...

Stop Atherosclerosis in Native Diabetics Study (SANDS)

Stop Atherosclerosis in Native Diabetics Study (SANDS)


clinicaltrials.gov

This study has been completed.
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)

Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00047424

Purpose
To compare aggressive lowering of low density lipoprotein (LDL) cholesterol and blood pressure to the usual care standard in Native American diabetics.



Condition Intervention Phase
Atherosclerosis
Cardiovascular Diseases
Heart Diseases
Diabetes Mellitus
Hypertension
Drug: simvastatin
Drug: ACE inhibitors
Phase III




MedlinePlus related topics: Diabetes Heart Diseases High Blood Pressure
Drug Information available for: Simvastatin Silicon dioxide
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized
Official Title: Stop Atherosclerosis in Native Diabetics Study (SANDS)


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):


Study Start Date: September 2002
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Detailed Description:
BACKGROUND:

Although once protected from cardiovascular disease (CVD), American Indians now have incidence rates higher than the general US population. The majority of CVD cases occur in individuals with diabetes. It is therefore imperative that intervention strategies to reduce CVD in diabetic individuals be developed and validated in this population.

DESIGN NARRATIVE:

The randomized three year trial examines the effects on cardiovascular disease (CVD) of intensive LDL reduction (goal less than or equal to75 mg/dL) and intensive blood pressure lowering (goal less than or equal to 115/75 mmHg), compared to usual targets of less than or equal to 100 mg/dL and less than or equal to 130/85 mmHg. These cutpoints were chosen because mean LDL and blood pressure levels are lower in this population, but there is a strong relation between LDL, blood pressure, and CVD at levels below current targets. The primary endpoint will be carotid intimal-medial thickness. Secondary endpoints will include cardiac function measures by echocardiography, lipoproteins, albuminuria, and C-reactive protein (CRP). The study will enroll 488 diabetic American Indian men and women more than 40 years of age and will be conducted in four field centers involving Indian Health/Tribal primary care facilities in Phoenix/Sacaton, Arizona; Chinle, Arizona; Rapid City/Pine Ridge, South Dakota; and Lawton, Oklahoma, with input from American Indian physicians and community members. Study results will provide evidence needed to develop community-based programs to treat and prevent the epidemic of CVD among American Indians. The data will also be valuable in understanding the effects of intensive risk-factor reduction on atherosclerosis burden and cardiac function in diabetic individuals in all US populations and provide evidence for determining LDL and blood pressure treatment goals for diabetic patients.

Eligibility


Ages Eligible for Study: 40 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria
No eligibility criteria

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00047424


Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Investigator: Barbara Howard Medstar Research Institute

More Information

No publications provided by National Heart, Lung, and Blood Institute (NHLBI)

Publications automatically indexed to this study:
Fleg JL, Mete M, Howard BV, Umans JG, Roman MJ, Ratner RE, Silverman A, Galloway JM, Henderson JA, Weir MR, Wilson C, Stylianou M, Howard WJ. Effect of statins alone versus statins plus ezetimibe on carotid atherosclerosis in type 2 diabetes: the SANDS (Stop Atherosclerosis in Native Diabetics Study) trial. J Am Coll Cardiol. 2008 Dec 16;52(25):2198-205.
Howard BV, Roman MJ, Devereux RB, Fleg JL, Galloway JM, Henderson JA, Howard WJ, Lee ET, Mete M, Poolaw B, Ratner RE, Russell M, Silverman A, Stylianou M, Umans JG, Wang W, Weir MR, Weissman NJ, Wilson C, Yeh F, Zhu J. Effect of lower targets for blood pressure and LDL cholesterol on atherosclerosis in diabetes: the SANDS randomized trial. JAMA. 2008 Apr 9;299(14):1678-89.

Study ID Numbers: 148
Study First Received: October 3, 2002
Last Updated: February 4, 2009
ClinicalTrials.gov Identifier: NCT00047424 history of changes since first registered
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Antimetabolites
Atherosclerosis
Arterial Occlusive Diseases
Heart Diseases
Metabolic Diseases
Simvastatin
Antilipemic Agents
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases
Anticholesteremic Agents
Arteriosclerosis
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Protease Inhibitors
Angiotensin-Converting Enzyme Inhibitors
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Hypertension



Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Enzyme Inhibitors
Cardiovascular Diseases
Pharmacologic Actions



ClinicalTrials.gov processed this record on February 27, 2009