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Stop Atherosclerosis in Native Diabetics Study (SANDS)

Primary Purpose

Cardiovascular Disease, Hypertension, Hyperlipidemia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
FDA approved drugs to treat blood pressure and cholesterol
Sponsored by
Cynthia West
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Disease focused on measuring lowering LDL and BP below current targets, LDL cholesterol treatment, blood pressure treatment, carotid intimal medial thickness, prevent progression of CVD

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: American Indian men and women 40 years of age or older Type 2 DM (according to 1997 ADA criteria and/or previously diagnosed by former ADA or WHO criteria): fasting plasma glucose >= 7.0 mmol/L (126 mg/dL) or 2-hour glucose >= 11.0 mmol/L (>200 mg/dL) after a 75-gram oral glucose tolerance test. LDL cholesterol >= 100 mg/dL. within the previous 12 months. Systolic BP >= 130 mm Hg. within the previous 12 months. Exclusion Criteria: New York Heart Association Stage III- IV congestive heart failure. SBP >180 mmHg (2% of population) or patients with known causes of hypertension. History of angioedema. Any medical condition that study physicians believe would interfere with study participation or evaluation of results. Mental incapacity and/or cognitive impairment on the part of the patient that would preclude adequate understanding of, or cooperation with, the study protocol. Serum hepatic transaminase levels 2X the upper limit of normal. Participation in any clinical trial of any investigational medication within 3 months prior to this trial. Renal insufficiency as indicated by serum creatinine >2.0 for women and >2.4 for men. Diagnosis of primary hyperlipidemia in medical record. Secondary hypercholesterolemia due to hypothyroidism or nephrotic syndrome. Patients on stable doses of thyroid replacement therapy will be eligible. Presence of malignancy or history of any cancer except skin cancer within the past 5 years. Pregnancy or lactation. Premenopausal women will be requested to use birth control methods throughout the study and provided educational materials about the risks of using the study medications during pregnancy. Unable to obtain quantifiable carotid measure during screening examination. Concomitant long term use of cyclosporins (Sandimmune), macrolide antibiotics (erythromycin -many generic and brand name forms, clarithromycin, Biaxin, and Zithromax), azole antifungals (itraconazole-Sporanox, ritonavir, Norvir, and nelfinavir (Viracept). Orthostatic hypotension as defined by the following: The individual has a measured fall of >20 mmHg in systolic BP upon standing associated with symptoms lasting more than one minute (or severe symptoms that would not allow further lowering of BP) The standing systolic blood pressure is less than 90 mm. Triglyceride level >350 mg/dl. Severe aortic stenosis with valve area <=1.0 square cm.

Sites / Locations

  • Chinle Comprehensive Health Care
  • Phoenix Indian Medical Center
  • USPHS Indian Hospital
  • Black Hills Center for American Indian Health

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

SANDS Control Group

SANDS Intervention Group

Arm Description

Standard Treatment for blood pressure and cholesterol

FDA approved drugs to treat blood pressure and cholesterol

Outcomes

Primary Outcome Measures

Changing LDL Cholesterol
LDL cholesterol intervention to lower targets than are currently recommended to retard atherosclerosis measured by LDL-C mg/dL. Scale: LDL cholesterol levels should be less than 100 mg/dL

Secondary Outcome Measures

Changing Blood Pressure
Treatment of blood pressure to prevent/reduce diseases of heart and blood vessels. Measured by mmHG. Normal values should be below 120/80 mm Hg.

Full Information

First Posted
September 2, 2005
Last Updated
June 15, 2021
Sponsor
Cynthia West
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1. Study Identification

Unique Protocol Identification Number
NCT00147251
Brief Title
Stop Atherosclerosis in Native Diabetics Study
Acronym
SANDS
Official Title
Stop Atherosclerosis in Native Diabetics Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
May 1, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Cynthia West

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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, fat,protein and inflammatory markers in the blood,and 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 Service/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.
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 mg/dL) and BP (goal < 115/75 mm Hg) reduction versus the standard goals of < 100 mg/dL for LDL-C and < 130/85 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 fatal/nonfatal 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 U.S. populations and will provide evidence for determining optimal LDL-C and BP treatment goals for diabetic patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease, Hypertension, Hyperlipidemia, Diabetes, Carotid Atherosclerosis
Keywords
lowering LDL and BP below current targets, LDL cholesterol treatment, blood pressure treatment, carotid intimal medial thickness, prevent progression of CVD

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
548 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SANDS Control Group
Arm Type
No Intervention
Arm Description
Standard Treatment for blood pressure and cholesterol
Arm Title
SANDS Intervention Group
Arm Type
Active Comparator
Arm Description
FDA approved drugs to treat blood pressure and cholesterol
Intervention Type
Drug
Intervention Name(s)
FDA approved drugs to treat blood pressure and cholesterol
Other Intervention Name(s)
No Intervention
Primary Outcome Measure Information:
Title
Changing LDL Cholesterol
Description
LDL cholesterol intervention to lower targets than are currently recommended to retard atherosclerosis measured by LDL-C mg/dL. Scale: LDL cholesterol levels should be less than 100 mg/dL
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Changing Blood Pressure
Description
Treatment of blood pressure to prevent/reduce diseases of heart and blood vessels. Measured by mmHG. Normal values should be below 120/80 mm Hg.
Time Frame
36 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: American Indian men and women 40 years of age or older Type 2 DM (according to 1997 ADA criteria and/or previously diagnosed by former ADA or WHO criteria): fasting plasma glucose >= 7.0 mmol/L (126 mg/dL) or 2-hour glucose >= 11.0 mmol/L (>200 mg/dL) after a 75-gram oral glucose tolerance test. LDL cholesterol >= 100 mg/dL. within the previous 12 months. Systolic BP >= 130 mm Hg. within the previous 12 months. Exclusion Criteria: New York Heart Association Stage III- IV congestive heart failure. SBP >180 mmHg (2% of population) or patients with known causes of hypertension. History of angioedema. Any medical condition that study physicians believe would interfere with study participation or evaluation of results. Mental incapacity and/or cognitive impairment on the part of the patient that would preclude adequate understanding of, or cooperation with, the study protocol. Serum hepatic transaminase levels 2X the upper limit of normal. Participation in any clinical trial of any investigational medication within 3 months prior to this trial. Renal insufficiency as indicated by serum creatinine >2.0 for women and >2.4 for men. Diagnosis of primary hyperlipidemia in medical record. Secondary hypercholesterolemia due to hypothyroidism or nephrotic syndrome. Patients on stable doses of thyroid replacement therapy will be eligible. Presence of malignancy or history of any cancer except skin cancer within the past 5 years. Pregnancy or lactation. Premenopausal women will be requested to use birth control methods throughout the study and provided educational materials about the risks of using the study medications during pregnancy. Unable to obtain quantifiable carotid measure during screening examination. Concomitant long term use of cyclosporins (Sandimmune), macrolide antibiotics (erythromycin -many generic and brand name forms, clarithromycin, Biaxin, and Zithromax), azole antifungals (itraconazole-Sporanox, ritonavir, Norvir, and nelfinavir (Viracept). Orthostatic hypotension as defined by the following: The individual has a measured fall of >20 mmHg in systolic BP upon standing associated with symptoms lasting more than one minute (or severe symptoms that would not allow further lowering of BP) The standing systolic blood pressure is less than 90 mm. Triglyceride level >350 mg/dl. Severe aortic stenosis with valve area <=1.0 square cm.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara V Howard, PhD
Organizational Affiliation
Medstar Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinle Comprehensive Health Care
City
Chinle
State/Province
Arizona
ZIP/Postal Code
86503
Country
United States
Facility Name
Phoenix Indian Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
USPHS Indian Hospital
City
Lawton
State/Province
Oklahoma
ZIP/Postal Code
73507
Country
United States
Facility Name
Black Hills Center for American Indian Health
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21788602
Citation
Roman MJ, Howard BV, Howard WJ, Mete M, Fleg JL, Lee ET, Devereux RB. Differential impacts of blood pressure and lipid lowering on regression of ventricular and arterial mass: the Stop Atherosclerosis in Native Diabetics Trial. Hypertension. 2011 Sep;58(3):367-71. doi: 10.1161/HYPERTENSIONAHA.111.172486. Epub 2011 Jul 25.
Results Reference
derived
PubMed Identifier
19095139
Citation
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. doi: 10.1016/j.jacc.2008.10.031.
Results Reference
derived
PubMed Identifier
18398080
Citation
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. doi: 10.1001/jama.299.14.1678.
Results Reference
derived

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Stop Atherosclerosis in Native Diabetics Study

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