Drugs for High Blood Pressure and High Cholesterol in American Indians With Type 2 Diabetes

• Status: Completed
• Trial end date: 1999-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Collaborator: Hennepin County Medical Center, Minneapolis
• Treatments: Lisinopril; Nifedipine; Simvastatin

Criteria

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