Patient Information for Clinical Trial on
"Improving Outcomes in Diabetic Nephropathy"

Diabetic nephropathy (a form of kidney disease in diabetics where protein leaks into the urine) is the leading cause of kidney failure around the world. There is currently no cure for diabetic nephropathy.

Several strategies are known to slow the progression of diabetic nephropathy, such as aggressive control of high blood pressure and diabetes. The use of ACE inhibitors (such as lisinopril) are known to slow the progression of diabetic nephropathy, independent of a person's blood pressure.

What is not yet clear is whether the addition of an 'aldosterone blocker' (spironolactone) or an 'angiotensin II blocker' (losartan) added to lisinopril would offer greater kidney protection than high dose lisinopril alone.

We are currently actively enrolling patients with diabetic nephropathy in a clinical trial to test this theory. Patients will be randomly placed into one of three groups: lisinopril + losartan or lisinopril + spironolactone or lisinopril + placebo. All three groups will have tight control of their blood pressure and be followed in our research. The time commitment of this trial is one year.

If you meet the following criteria for our trial and are interested in learning more, please contact Margarita Dominguez, RN, Study Coordinator at phone: 214-648-7847 or Justin Teiwes, M.D., co-investigator, at pager: 214-822-0769, Monday-Friday 8am-4pm.

Criteria
*Males and females of all ethnic background, ages 20-60
*Type I or Type 2 diabetes mellitus
*High blood pressure or receiving treatment for high blood pressure
*Proteinuria (protein in the urine)

Patients with the following criteria can not participate in the trial:
*Heart attack in the last year
*Advanced heart failure
*Pregnant or attempting to become pregnant in the next year