Type 1 Diabetes Clinical Trial
Official title:
Renin Angiotensin System Blockage-DN (RASS)
To determine if renin angiotensin medications can prevent or delay the onset of diabetic kidney disease.
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 and/or systemic blood pressure (BP) on
the development and progression of diabetic retinopathy. This ancillary study has the
following aims:
Specific Aim To obtain baseline, 2.5 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
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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