URL: http://clinicaltrials.gov/show/NCT00143949
Proper Citation: Renin Angiotensin System Study (RRID:SCR_013385)
Description: Randomized, multicenter, double-blind study to determine if renin angiotensin medications, either losartan (angiotensin II blocker) or enalapril (converting enzyme inhibitor), can prevent or delay the onset of diabetic kidney disease in patients with type 1 diabetic patients who do not have hypertension, diabetic nephropathy, or predictive levels of microalbuminuria. Two hundred eight five patients ages 16-61 with 2-20 yrs of Type 1 Diabetes Mellitus and no renal functional abnormalities were randomized into a parallel, double-blind, placebo-controlled study involving 3 groups (95 patients/group). Each group received an angiotensin-converting enzyme inhibitor (ACEI) (enalapril), or an angiotensin II receptor blocker (Losartan), or placebo. All patients had their usual Diabetes Mellitus (DM) management. Baseline studies included measures of glomerular filtration rate (GFR), urinary albumin excretion rate (UAE), blood pressure (BP), and a percutaneous renal biopsy. Patients were followed by quarterly measures of BP, HbA1C, UAE, and drug compliance. There were annual measures of GFR and a repeat renal biopsy after 5 yrs in the study. The main endpoint is kidney structural changes over time, especially mesangial fractional volume (v(Mes/glom)). Secondary endpoints will be other DN structural measures and measures of kidney function (UAE, GFR). These studies will determine whether rennin angiotensin system blockage in the early stages of DN can prevent the early kidney structural changes in this important disorder. Ancillary studies will evaluate the effects of treatment group on the development and progression of diabetic retinopathy and will develop predictors of study participants'''' compliance. Baseline, 2.5 and 5 year retinal fundus photographs in the RASS patients were obtained.
Abbreviations: RASS/B-RASS, RASS
Synonyms: Renin Angiotensin System Blockage-DN (RASS), Renin Angiotensin System Study (RASS/B-RASS)
Resource Type: clinical trial, resource
Defining Citation: PMID:19571282
Keywords: enalapril, drug, losartan, angiotensin, medication, kidney, intervention, clinical, adolescent, adult human, renal biopsy, renin-angiotensin system, diabetic nephropathy, kidney, placebo, glomerular filtration rate, urinary albumin excretion rate, blood pressure
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