Stop Atherosclerosis in Native Diabetics Study

This study has been completed.
Sponsor:
Information provided by:
Medstar Research Institute
ClinicalTrials.gov Identifier:
NCT00147251
First received: September 2, 2005
Last updated: October 31, 2006
Last verified: September 2005
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Stop Atherosclerosis in Native Diabetics Study

Resource links provided by NLM:


Further study details as provided by Medstar Research Institute:

Primary Outcome Measures:
  • combined carotid artery intimal medial thickness measured at 3 years and clinical CVD events tracked throughout the 3 years

Secondary Outcome Measures:
  • left ventricular (LV) function and geometry
  • level of stenosis of the carotid artery
  • number of plaques in the carotid artery
  • various safety measures, such as liver enzyme levels, clinical myositis, postural hypotension, glomerular filtration rate, urine albumin/creatinine ratio

Estimated Enrollment: 548
Study Start Date: May 2003
Estimated Study Completion Date: May 2007
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. American Indian men and women 40 years of age or older
  2. 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.
  3. LDL cholesterol >= 100 mg/dL. within the previous 12 months.
  4. Systolic BP >= 130 mm Hg. within the previous 12 months.

Exclusion Criteria:

  1. New York Heart Association Stage III- IV congestive heart failure.
  2. SBP >180 mmHg (2% of population) or patients with known causes of hypertension.
  3. History of angioedema.
  4. Any medical condition that study physicians believe would interfere with study participation or evaluation of results.
  5. Mental incapacity and/or cognitive impairment on the part of the patient that would preclude adequate understanding of, or cooperation with, the study protocol.
  6. Serum hepatic transaminase levels  2X the upper limit of normal.
  7. Participation in any clinical trial of any investigational medication within 3 months prior to this trial.
  8. Renal insufficiency as indicated by serum creatinine >2.0 for women and >2.4 for men.
  9. Diagnosis of primary hyperlipidemia in medical record.
  10. Secondary hypercholesterolemia due to hypothyroidism or nephrotic syndrome. Patients on stable doses of thyroid replacement therapy will be eligible.
  11. Presence of malignancy or history of any cancer except skin cancer within the past 5 years.
  12. 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.
  13. Unable to obtain quantifiable carotid measure during screening examination.
  14. 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).
  15. Orthostatic hypotension as defined by the following:

    1. 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)
    2. The standing systolic blood pressure is less than 90 mm.
  16. Triglyceride level >350 mg/dl.
  17. Severe aortic stenosis with valve area <=1.0 square cm.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00147251

Locations
United States, Arizona
Chinle Comprehensive Health Care
Chinle, Arizona, United States, 86503
Phoenix Indian Medical Center
Phoenix, Arizona, United States, 85016
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
Sponsors and Collaborators
Medstar Research Institute
Investigators
Principal Investigator: Barbara V Howard, PhD Medstar Research Institute
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00147251     History of Changes
Other Study ID Numbers: 2000-285, Grant # 1 U01 HL67031
Study First Received: September 2, 2005
Last Updated: October 31, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Medstar Research Institute:
lowering LDL and BP below current targets
LDL cholesterol treatment
blood pressure treatment
carotid intimal medial thickness
prevent progression of CVD

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Cardiovascular Diseases
Hyperlipidemias
Hypertension
Carotid Artery Diseases
Arterial Occlusive Diseases
Vascular Diseases
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 21, 2014