Drugs for High Blood Pressure and High Cholesterol in American Indians With Type 2 Diabetes
| Status: | Completed |
|---|---|
| Conditions: | Diabetic Neuropathy, Renal Impairment / Chronic Kidney Disease, Diabetes |
| Therapuetic Areas: | Endocrinology, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | August 1993 |
| End Date: | July 1999 |
Randomized Study of Antihypertensives and Antilipemics in American Indians With Non-Insulin-Dependent Diabetes Mellitus at High Risk of Developing Nephropathy and Cardiovascular Disease
OBJECTIVES:
I. Establish a long-term working relationship between clinical investigators and the
Minnesota American Indian community.
II. Compare the effectiveness of lisinopril (an angiotensin-converting enzyme inhibitor) and
nifedipine (a calcium channel blocker) in preventing nephropathy and vascular disease in
Minnesota American Indians with non-insulin-dependent diabetes mellitus and microalbuminuria.
III. Compare the effectiveness of simvastatin (a 3-hydroxy-3-methylglutaryl coenzyme A
reductase inhibitor) with lipid-lowering strategies recommended by the National Cholesterol
Education Program in preventing nephropathy and vascular diseases in these patients.
I. Establish a long-term working relationship between clinical investigators and the
Minnesota American Indian community.
II. Compare the effectiveness of lisinopril (an angiotensin-converting enzyme inhibitor) and
nifedipine (a calcium channel blocker) in preventing nephropathy and vascular disease in
Minnesota American Indians with non-insulin-dependent diabetes mellitus and microalbuminuria.
III. Compare the effectiveness of simvastatin (a 3-hydroxy-3-methylglutaryl coenzyme A
reductase inhibitor) with lipid-lowering strategies recommended by the National Cholesterol
Education Program in preventing nephropathy and vascular diseases in these patients.
PROTOCOL OUTLINE:
Patients are randomly assigned to 1 of 4 treatment groups; therapy continues for 3 years. All
patients receive instruction on diet, exercise, and smoking cessation.
The first group receives daily nifedipine at a dose adjusted for high blood pressure.
Cholestyramine or gemfibrozil is administered per National Cholesterol Education Program
guidelines. Diuretics and doxazosin may be given concurrently.
The second group receives daily lisinopril at a dose adjusted for high blood pressure.
Cholestyramine or gemfibrozil is administered per National Cholesterol Education Program
guidelines. Diuretics and doxazosin may be given concurrently.
The third group receives daily nifedipine at a dose adjusted for high blood pressure, and
simvastatin at a dose adjusted for high low-density lipoproteins. Supplemental cholestyramine
may be given as needed. If cholestyramine is not tolerated or if triglycerides are high,
gemfibrozil is substituted for cholestyramine.
The fourth group receives lisinopril at a dose adjusted for high blood pressure and
simvastatin at a dose adjusted for high low-density lipoproteins.
Patients are randomly assigned to 1 of 4 treatment groups; therapy continues for 3 years. All
patients receive instruction on diet, exercise, and smoking cessation.
The first group receives daily nifedipine at a dose adjusted for high blood pressure.
Cholestyramine or gemfibrozil is administered per National Cholesterol Education Program
guidelines. Diuretics and doxazosin may be given concurrently.
The second group receives daily lisinopril at a dose adjusted for high blood pressure.
Cholestyramine or gemfibrozil is administered per National Cholesterol Education Program
guidelines. Diuretics and doxazosin may be given concurrently.
The third group receives daily nifedipine at a dose adjusted for high blood pressure, and
simvastatin at a dose adjusted for high low-density lipoproteins. Supplemental cholestyramine
may be given as needed. If cholestyramine is not tolerated or if triglycerides are high,
gemfibrozil is substituted for cholestyramine.
The fourth group receives lisinopril at a dose adjusted for high blood pressure and
simvastatin at a dose adjusted for high low-density lipoproteins.
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- Non-insulin-dependent diabetes mellitus with documented fasting
hyperglycemia Microalbuminuria OR clinically detectable albuminuria; Urine albumin
excretion rate at least 30 mg/24 hours Low-density lipoproteins (fasting) at least 80 mg/dL
Recruitment from American Indian population at Red Lake and Leech Lake reservations
--Prior/Concurrent Therapy-- At least 5 days since antihypertensives or antilipemics
--Patient Characteristics-- Renal: Urine albumin-to-creatinine ratio at least 30 mg/g;
Creatinine clearance or estimated creatinine clearance at least 30 mL/min; No active urine
sediment suggestive of glomerulonephritis, i.e.: No RBCs greater than 10/high-power field;
No WBCs greater than 15/high-power field; No RBC casts
Cardiovascular: No symptomatic orthostatic hypotension; No poorly-compensated congestive
heart failure; No requirement for angiotensin-converting enzyme inhibitors; No angina
pectoris requiring nifedipine; No unstable angina; No episodes of angina occurring more
than once a month; No chest pain of undetermined cause within 1 month; No severe
hypertension requiring multiple antihypertensives; No myocardial infarction within 1 year;
No stroke or transient ischemic attack within 1 year
Other: No known allergy to nifedipine, lisinopril, or simvastatin; No untreated
proliferative retinopathy; Documented retinal exam within 1 year prior to entry; No alcohol
or drug abuse affecting compliance; No other debilitating or acute illness; No pregnant or
nursing women; Effective contraception required of fertile women
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