Type 2 Diabetes Clinical Trial
Official title:
Effect of Angiotensin Converting Enzyme Inhibitor, Lisinopril, on Renal Blood Flow and Its Correlation With Proteinuria Reduction in Subjects With Type 2 Diabetes and Kidney Disease (KXK005).
The purpose of the study is to investigate the effect of a blood pressure medication, Lisinopril, or similar drugs in that class, on the flow of blood to the kidneys. In this study, we will compare blood flow to the kidneys in healthy people that do not have diabetes or kidney disease with people that have diabetes and evidence of kidney disease.
Blockers of renin angiotensin aldosterone system (RAAS) are considered the standard of care
in treatment of diabetic nephropathy. Their effects are thought to be through multiple
mechanisms, including reducing intraglomerular pressure. However, due to the lack of a
sensitive, practical and noninvasive method of monitoring renal hemodynamics, the magnitude
of hemodynamic effects of these agents and its contribution to proteinuria reduction has not
been studied in humans. At the same time, it is not clear if treatment with blockers of the
RAAS have similar renal hemodynamic effects in individuals with and without diabetes and
kidney disease.
Up to 36 subjects with type 2 diabetes and more than 150 mg of proteinuria who are on stable
doses of ACE inhibitors or angiotensin receptor blockers (ARBs) and up to 18 healthy
volunteers will be enrolled in this study. Subjects with type 2 diabetes will be asked to
stop their ACE inhibitor or ARB medications for 10 days. Between 7 to 10 days after stopping
these medications renal blood flow (RBF) will be measured using contrast enhanced ultrasound
(CEU) and urine protein will be measured as well for comparison to baseline. Subjects' ACE
inhibitors or ARB will be restarted and RBF measurement using CEU and measurement of urine
protein excretion will be repeated after 7 days. For comparison, RBF will be measured by CEU
in up to 18 healthy volunteers. They will then be started on Lisinopril 10 mg orally once a
day for 7 days. On day 7 RBF measurement will be repeated to assess the effect of ACE
inhibitors on RBF in healthy individuals as compared to those with diabetic nephropathy.
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