| Ad Title: |
Diabetic Nephropathy |
| Study Title: |
Improving Outcomes in Diabetic Nephropathy--Clone Created |
| Protocol Number: |
0202-065 |
| Department(s) involved in the Study: |
Int Med - Nephrology
|
| Purpose of the Study: |
The purpose of this research is to determine whether adding on a medication to standard treatment prevents your kidney disease from getting worse. This research is being done because diabetes is the number one cause of kidney failure. Current standard treatment does not cure the disease and it gets worse leading to the need for dialysis (artificial kidney treatments) or kidney transplantation. |
| Participant Eligibility: |
1. Adult male and female subjects aged 20-65 of all ethnic backgrounds.
2. Type I diabetes mellitus defined as sudden onset of diabetes requiring insulin prior to age 20 and at least 5 years duration.
3. Type 2 diabetes mellitus defined as onset > or = to 20 years of age and treatment with oral hypoglycemic agent and/or insulin and increased C-peptide level.
4. Seated SPB > 130 mmHg documented at one screening visit or treated SBP < 130 mmHg with a documented history of SBP > 130 mmHg on more than one previous occasion.
5. Proteinuria defined as a 24-hour urine albumin/creatinine ratio > or = to 200 mg/g while on an ACE inhibitor with or without non-ARB, non-aldosterone antagonist treatment.
6. Ongoing treatment (> or = to 3 months) with an ACE inhibitor or ARB with or without additional antihypertensive therapy (e.g. CCB, a-blocker, b-blocker, Clonidine).
|
| Disease/Condition Under Study: |
Diabetic Nephropathy. |
| Cancer Related Study: |
No
|
| Study Drug(s): |
Losartan, spironolactone
|
| Study Device(s): |
|
| Study Doctor: |
Dr. Robert Toto |
| Location of Study: |
|
Sites
|
Recruiting at this Site
|
|
Parkland Memorial Hospital
|
Yes
|
|
Aston Ambulatory Care Center
|
Yes
|
|
General Clinical Research Center
|
Yes
|
|
| Contact Phone: |
214-648-7847 |
| Email: |
suzan.morrison@utsouthwestern.edu |
| Other Information: |
This is a 12-month NIH - sponsored study for the treatment of proteinuria in Type 1 and Type 2 Diabetics with FDA approved drugs: Open-labeled Lisinopril 80 mg QD, and blinded to either Losartan 50-100 mg, Aldactone 12.5 to 25 mg. or placebo. All patients will be given Lisinopril 80 mg QD and randomized to one of the three-blinded arms of the study. All study related blood pressure medications, clinic visits and laboratory tests are at no cost to the patients. |
| Website Keywords: |
Diabetes, Nephrology
|
| Medical Keywords: |
Diabetic Nephropathy
|
