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Trial NCT00143949

Resource URI: http://static.linkedct.org/resource/trials/NCT00143949
linkedct:brief_title Renin Angiotensin System Study (RASS/B-RASS)
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/1060>
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/5051>
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/5053>
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/5455>
linkedct:condition <http://static.linkedct.org/resource/condition/13325>
linkedct:criteria Inclusion Criteria: - type 1 diabetic (DM) for 2-20 yrs - type 1 DM onset prior to 45; if onset was between ages 31-41, BMI <26; onset 41-45, positive GAD or ICA required - normal or increased GFR - normal BP - normoalbuminuric (<20 ug/min on 2 of 3 time overnight urine collections) Exclusion Criteria: - type 1 DM duration longer than 20 yrs - hypertension (>85/135 mmHg) - reduced GFR (<90 ml/min/1.73m2) - microalbuminuria - solitary kidney or evidence of unilateral renal disease - evidence of other important kidney disease by history, ultrasound or biopsy - other chronic diseases or conditions such as cystic fibrosis, serious mental illness, severe mental retardation, etc. - pregnancy or females planning pregnancy within 2 years were excluded due to the drugs being used - compliance (pt not taking at least 85% of two week placebo were excluded)
linkedct: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 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
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers Accepts Healthy Volunteers
linkedct:eligibility_maximum_age 61 Years
linkedct:eligibility_minimum_age 16 Years
linkedct:end_date May 2008
linkedct:enrollment 285 (xsd:int)
linkedct:firstreceived_date September 1, 2005
linkedct:has_dmc Yes
linkedct:id NCT00143949
rdfs:label Trial NCT00143949
linkedct:lastchanged_date November 5, 2008
linkedct:lead_sponsor_agency Michael Mauer, MD
linkedct:location <http://static.linkedct.org/resource/location/17795>
linkedct:location <http://static.linkedct.org/resource/location/17887>
linkedct:location <http://static.linkedct.org/resource/location/20404>
linkedct:nct_id NCT00143949
linkedct:number_of_arms 3 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Renin Angiotensin System Blockage-DN (RASS)
linkedct:org_study_id 9601M10705
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/52440>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
linkedct:oversight <http://static.linkedct.org/resource/oversight/2920>
foaf:page <http://clinicaltrials.gov/show/NCT00143949>
linkedct:phase Phase 2
linkedct:primary_completion_date March 2007
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/45244>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/45245>
linkedct:reference <http://static.linkedct.org/resource/reference/16341>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/124363>
linkedct:source University of Minnesota - Clinical and Translational Science Institute
linkedct:start_date March 1997
linkedct:study_design Other, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
linkedct:study_type Interventional
linkedct:summary To determine if renin angiotensin medications can prevent or delay the onset of diabetic kidney disease.
rdf:type linkedct:trials
linkedct:verification_date November 2008