Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00143949
Status:
COMPLETED
Last Update Posted:
2008-11-06
First Post:
2005-09-01
Brief Title:
Renin Angiotensin System Study RASSB-RASS
Sponsor:
Michael Mauer MD
Organization:
University of Minnesota
Study Overview
Official Title:
Renin Angiotensin System Blockage-DN RASS
Status:
COMPLETED
Status Verified Date:
2008-11
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:
To determine if renin angiotensin medications can prevent or delay the onset of diabetic kidney disease
Detailed Description:
The primary objective of this research is to determine in type 1 insulin-dependent diabetic patients without hypertension diabetic nephropathy DN or levels of microalbuminuria MA predictive of underlying already established serious lesion of diabetic nephropathy if inhibition of renin-angiotensin system RAS activity can prevent or retard the rate of development of the histologic lesions associated with DN This primary prevention study is designed to examine the effect of pharmacologic intervention on the earliest stages of diabetic kidney disease At the stage of overt DN intervention studies have shown only a slowing as opposed to arrest in disease progression and benefit a minority of treated patients At the MA stage the renal lesions of DN are already usually firmly established moreover progression in MA patients may occur despite strict glycemic or anti-hypertensive control Renal histologic change over time has been selected as the primary endpoint in order to study the early stages of this disease since the time to functional endpoints from these earlier stages precludes practical study design
Specific Aim 1 To recruit 285 type 1 diabetic patients who do not have hypertension diabetic nephropathy or predictive levels of microalbuminuria into a 5-year study to determine the effect of inhibition of renin-angiotensin system activity with either losartan angiotensin II blocker or enalapril converting enzyme inhibitor on the development of diabetic renal disease This aim has been accomplished and the study is entitled the Renin-Angiotension System Study RASS
Specific Aim 2 To obtain two percutaneous renal biopsies from each patient the first at entry into the study and the second after five years of drug therapy with either losartan or enalapril
Hypothesis Reduction of renin-angiotensin system activity will prevent or retard the development of histologic change in the kidney associated with diabetic nephropathy
A secondary objective of this study is to evaluate retinal lesions in the RASS cohort of patients in order to determine the relationship of these findings to the histologic changes of DN and to examine the effects of RAS inhibition andor systemic blood pressure BP on the development and progression of diabetic retinopathy This ancillary study has the following aims
Specific Aim To obtain baseline 25 and 5 year retinal fundus photographs in the RASS patients
Hypothesis Cross-sectional and longitudinal relationships of retinal and renal structural abnormalities will emerge which will improve the predictive value of renal functional tests Reduction of rennin-angiotensin system activity will prevent or retard the development of diabetic retinal lesions
Specific Aim 1 To recruit 285 type 1 diabetic patients who do not have hypertension diabetic nephropathy or predictive levels of microalbuminuria into a 5-year study to determine the effect of inhibition of renin-angiotensin system activity with either losartan angiotensin II blocker or enalapril converting enzyme inhibitor on the development of diabetic renal disease This aim has been accomplished and the study is entitled the Renin-Angiotension System Study RASS
Specific Aim 2 To obtain two percutaneous renal biopsies from each patient the first at entry into the study and the second after five years of drug therapy with either losartan or enalapril
Hypothesis Reduction of renin-angiotensin system activity will prevent or retard the development of histologic change in the kidney associated with diabetic nephropathy
A secondary objective of this study is to evaluate retinal lesions in the RASS cohort of patients in order to determine the relationship of these findings to the histologic changes of DN and to examine the effects of RAS inhibition andor systemic blood pressure BP on the development and progression of diabetic retinopathy This ancillary study has the following aims
Specific Aim To obtain baseline 25 and 5 year retinal fundus photographs in the RASS patients
Hypothesis Cross-sectional and longitudinal relationships of retinal and renal structural abnormalities will emerge which will improve the predictive value of renal functional tests Reduction of rennin-angiotensin system activity will prevent or retard the development of diabetic retinal lesions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None