Stop Atherosclerosis in Native Diabetics Study
Condition: Cardiovascular Disease; Hypertension; Hyperlipidemia; Diabetes; Carotid Atherosclerosis
MeSH terms: Carotid Artery Diseases; Cardiovascular Diseases; Atherosclerosis; Hyperlipidemias
Intervention: FDA approved drugs to treat blood pressure and cholesterol
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 548.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: lowering LDL and BP below current targets; LDL cholesterol treatment; blood pressure treatment; carotid intimal medial thickness; prevent progression of CVD

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.
    

Eligibility 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.