you may be eligible for a new study to prevent kidney disease in people with Type I diabetes.
Who can join the study?
18-64 years of age
Type I [insulin dependent] diabetes for 2-20 years
Diabetes diagnosed before age 45
Normal kidney function
Normal blood pressure
Why should I join the study?
You will be closely monitored for hypertension, kidney function, and progression of diabetic complications.
You will be part of an important research program to determine if we can prevent or delay diabetic kidney disease.
This information could help others, including those in your family, who have or may develop diabetes.
About the study:
Kidney diseases occurs in 30% of people with Type I Diabetes. This study will determine if we can prevent or delay the development of diabetic kidney disease by using special drug therapy.
For more information call:
University of Minnesota
Trudy Strand, RN,CDE Project Manager
(612) 625-2996
1-888-256-9787 extension 52996
or email her at stran020@maroon.tc.umn.edu
Renin-Angiotensin System Study (RASS)
Summary for Patients A Study of The Early Treatment of Diabetic Kidney
Disease With Antihypertensive Medications
The RASS study is a medical research trial which is designed to determine if certain drugs used to treat high blood pressure (antihypertensive medications) can slow or stop the development of the early stages of diabetic kidney disease. This study is conducted by the University of Minnesota in collaboration with medical centers in Montreal, and Toronto, Canada. Approximately 255 people at these medical centers will participate in this study.
Background Information
People with Type I, or insulin-dependent diabetes, have a 25-35% risk of developing serious kidney disease which is called diabetic nephropathy. This kidney disease leads to kidney failure 15-40 years after diabetes first begins.
Diabetic nephropathy develops silently for the first 10-30 years of insulin dependent diabetes mellitus. By the time warning signs such as high blood pressure, increased protein loss in the urine, or a drop in the filtering ability of the kidney are detectable, kidney damage has already reached a stage where treatment can slow, but probably not stop, the progress toward kidney failure.
Currently, there are no indirect ways (such as blood or urine tests or blood pressure measurement) to detect the earliest stages of diabetic kidney disease. Thus, for many years after the onset of diabetes, doctors are unable to distinguish people who will develop serious complications from those whose kidney function will remain normal.
Purpose of the Study
The study has been designed to determine whether certain antihypertensive medications can slow or stop the development of early diabetic kidney damage. The renin-angiotensin system, one of the regulators of blood pressure, might play a role in the development of diabetic kidney disease. This could be because of influences on blood flow and pressure within the kidney which could be damaging to diabetic patients. Alternately, the renin-angiotensin system might influence the production of certain proteins which can accumulate in the filter system of the kidney and lead to structural damage in the kidney.
There are two types of antihypertensive drugs which can block the renin-angiotensin system. The first, angiotensin converting enzyme inhibitors such as enalapril (Vasotec), blocks the production of angiotensin, the molecule that affects the kidney. The second, angiotensin receptor blockers such as losartan (Lozaar), blocks the interaction of angiotensin with kidney cells. These drugs are currently being given to people with advanced kidney disease, and it appears as though they may slow, or stop, the progression of the disease. The purpose of this study is to see if, by giving these drugs before the kidney disease has started, we can prevent it from developing at all.
As these two drugs act somewhat differently, both will be tested in this study. It would not be possible to prove a benefit of these drugs unless some patients did not receive this treatment. Therefore, participants will have initial (baseline) studies of kidney function and a kidney biopsy and then be randomly assigned to one of three groups. One group will receive the angiotensin converting enzyme inhibitor, enalapril; the second group will receive the angiotensin receptor blocker, losartan; and the third group will receive a pill without active ingredients (placebo). Neither you nor the doctors or nurses in this study will know which group you have been assigned to until after the study has been completed. At the end of the five year study we will be able to determine whether either or both of the active drugs were able to slow the rate of development of the structural changes of diabetes in the kidney.
Eligibility Requirements
You may be eligible for this study if you:
1) are between 18-64 years old
2) have had insulin-dependent diabetes for at least 2, but less than 20 years.
3) were diagnosed with diabetes before the age of 45
4) have normal blood pressure
5) have normal kidney function
6) are not planning a pregnancy within the next 2 years
7) are not planning a move out of the area for the next five years
Quarterly Study Visits
If you choose to join the five year study, you will have kidney tests done in the Clinical Research Center at the Fairview-University Medical Center. These tests will be directed by Michael Mauer, M.D., a doctor who is a nephrologist (kidney specialist) and a leading authority in the field of diabetic kidney disease. During the study you will be asked to continue regular visits to your own diabetes specialist as well as to briefly visit the nurse coordinator at our study center every three months. You will be asked to bring an overnight urine collection to each visit. In addition, we will do three blood pressures and a fingerstick blood for glycosylated hemoglobin (A1c). If you are female, we will do a blood draw for a pregnancy test at each of these visits. The cost of the medical care, blood and kidney function tests, and study medications that are required by this research study will be free of charge to you. The cost of diabetes related clinic visits to your private physician and other treatment recommended as a routine part of your diabetes management, including the cost of blood glucose testing supplies, will continue to be paid for by you and/or your health insurance.
Confidentiality
Any information obtained in connection with this research study that can be identified with you will remain confidential and will be disclosed only with your permission. In any written reports or publications, you will not be identified or identifiable. As a volunteer, if you decide you do not wish to, or are unable to have the tests required by this study, you may refuse to participate and your care will continue as before.
Contacts and Questions
If you have further questions you may reach the Project Manager, Trudy Strand, RN, CDE or the study director, Dr. Michael Mauer at (612) 625-2996 or 1-888-256-9787 extension 52996.
