Study of Drugs for High Blood Pressure and High Cholesterol in American Indians With Type 2 Diabetes at High Risk of Kidney or Heart Disease

This study has been completed.
Sponsor:
Collaborator:
Hennepin County Medical Center, Minneapolis
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004266
First received: October 18, 1999
Last updated: June 23, 2005
Last verified: December 2001
  Purpose

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.


Condition Intervention
Diabetic Nephropathy
Drug: Lisinopril
Drug: nifedipine
Drug: simvastatin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
Official Title: Randomized Study of Antihypertensives and Antilipemics in American Indians With Non-Insulin-Dependent Diabetes Mellitus at High Risk of Developing Nephropathy and Cardiovascular Disease

Resource links provided by NLM:


Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 160
Study Start Date: August 1993
Estimated Study Completion Date: July 1999
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  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: NCT00004266

Sponsors and Collaborators
Hennepin County Medical Center, Minneapolis
Investigators
Study Chair: Bertram L. Kasiske Hennepin County Medical Center, Minneapolis
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00004266     History of Changes
Other Study ID Numbers: 199/11643, UMN-1967
Study First Received: October 18, 1999
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):
diabetic nephropathy
rare disease
renal and genitourinary disorders

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetic Nephropathies
Kidney Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on October 29, 2014