Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004266
Status:
COMPLETED
Last Update Posted:
2018-03-07
First Post:
1999-10-18
Brief Title:
Drugs for High Blood Pressure and High Cholesterol in American Indians With Type 2 Diabetes
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UMN-1967 | OTHER | None | None |
| R01DK047112 | NIH | Hennepin County Medical Center Minneapolis | httpsreporternihgovquickSearchR01DK047112 |