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Stop Atherosclerosis in Native Diabetics Study (SANDS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00047424
First Posted: October 4, 2002
Last Update Posted: February 5, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Prevention
Official Title: Stop Atherosclerosis in Native Diabetics Study (SANDS)

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
No eligibility criteria
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00047424


Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
OverallOfficial: Barbara Howard Medstar Health Research Institute
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00047424     History of Changes
Other Study ID Numbers: 148
First Submitted: October 3, 2002
First Posted: October 4, 2002
Last Update Posted: February 5, 2009
Last Verified: August 2008

Additional relevant MeSH terms:
Diabetes Mellitus
Cardiovascular Diseases
Heart Diseases
Atherosclerosis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Simvastatin
Angiotensin-Converting Enzyme Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Protease Inhibitors