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| Sponsored by: |
Medstar Research Institute |
|---|---|
| Information provided by: | Medstar Research Institute |
| ClinicalTrials.gov Identifier: | NCT00147251 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cardiovascular Disease Hypertension Hyperlipidemia Diabetes Carotid Atherosclerosis |
Drug: FDA approved drugs to treat blood pressure and cholesterol |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Stop Atherosclerosis in Native Diabetics Study |
| Estimated Enrollment: | 548 |
| Study Start Date: | May 2003 |
| Estimated Study Completion Date: | May 2007 |
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.
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
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.
Exclusion Criteria:
Orthostatic hypotension as defined by the following:
Contacts and Locations| United States, Arizona | |
| Phoenix Indian Medical Center | |
| Phoenix, Arizona, United States, 85016 | |
| Chinle Comprehensive Health Care | |
| Chinle, Arizona, United States, 86503 | |
| United States, Oklahoma | |
| USPHS Indian Hospital | |
| Lawton, Oklahoma, United States, 73507 | |
| United States, South Dakota | |
| Black Hills Center for American Indian Health | |
| Rapid City, South Dakota, United States, 57701 | |
| Principal Investigator: | Barbara V Howard, PhD | Medstar Research Institute |
More Information
| Study ID Numbers: | 2000-285, Grant # 1 U01 HL67031 |
| Study First Received: | September 2, 2005 |
| Last Updated: | October 31, 2006 |
| ClinicalTrials.gov Identifier: | NCT00147251 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
lowering LDL and BP below current targets LDL cholesterol treatment blood pressure treatment carotid intimal medial thickness prevent progression of CVD |
|
Atherosclerosis Arterial Occlusive Diseases Hyperlipidemias Metabolic Diseases Diabetes Mellitus Disease Progression Vascular Diseases Central Nervous System Diseases |
Arteriosclerosis Brain Diseases Cerebrovascular Disorders Carotid Artery Diseases Metabolic Disorder Dyslipidemias Hypertension Lipid Metabolism Disorders |
|
Atherosclerosis Arterial Occlusive Diseases Hyperlipidemias Metabolic Diseases Nervous System Diseases Vascular Diseases Central Nervous System Diseases Arteriosclerosis |
Brain Diseases Cerebrovascular Disorders Cardiovascular Diseases Carotid Artery Diseases Dyslipidemias Hypertension Lipid Metabolism Disorders |
