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PREVENTKD ( Prevent Risk by Early interVEntion at Nighttime in Type 1 diabetes for Kidney Disease)

Principal Investigator: Daniel Batlle, MD, Northwestern University Feinberg School of Medicine

CO-INVESTIGATORS
Northwestern:  Drs Mark Molitch & Daniel Dunham
Evanston Northwestern Healthcare:  Drs Lisa Purdy & Herman Blomeier
Rush University Medical Center:  Drs Alex Lurie & David Baldwin
Loyola University Chicago:  Drs Maryann Emanuel & Carla Minutti
The University of Chicago:  Drs George Bakris & Lou Philipson
The University of Illinois at Chicago:  Drs Elena Barengolts & Theodore Mazzone

Study Sponsored by the National Institute of Health and Juvenile Diabetes Research Foundation

Why is prevention of kidney complications and hypertension important?

Fortunately not everyone with Type 1 Diabetes develops kidney complications or hypertension.  Therefore there is no need to treat everyone in an effort to prevent these complications but it is important to develop tools that will help in the future to identify those individuals that are at risk as well as to gather good clinical evidence that treatment will work if started early on. This study’s main goal is to see if in the long term early treatment is beneficial to prevent kidney complication of diabetes called microalbuminuria.

Type 1 Diabetes facts

• Previously known as juvenile diabetes or insulin-dependent diabetes typically appearing during childhood or adolescence but can develop at any age.
• A chronic condition in which the pancreas produces little or no insulin, a hormone needed to convert sugar (glucose), starches and other food into energy.
• Having type 1 diabetes increases your risk for heart disease, blindness, nerve damage, and kidney damage.
• Early diagnosis of kidney complications is likely the key to its prevention
  

What is a Clinical research Study?

Clinical research studies try to answer specific questions regarding the safety and effectiveness of a specific drug, device, or treatment. Clinical trials are extensively regulated by the Food and Drug Administration (FDA) the Department of Health and Human Services (DHHS) and the Institutional Review Board (IRB).

A clinical trial participant works with a research team that includes doctors, nurses and other healthcare professionals.  Both the participant’s and the study team’s commitment is important to help the study to reach its goals. 

Participating in a clinical trial is a very important decision.  It should be thought out carefully.  You should never feel obligated to be involved in a research study.  If you do choose to participate, you will be free to withdraw from the study at any time for any reason.

You may qualify for this study if you:

• Have been diagnosed with Type 1 Diabetes, duration of between 5 - 28 years
  
• Are between the ages of 13-50
  
• Have no evidence of kidney disease or high blood pressure

How can I participate?

If you think you would like to participate, please call one of the phone numbers under contacts.  You will be asked to start the screening at one of the locations listed.  The purpose of the screening is to determine if you meet all the qualifications for enrollment into the study.

During the screening the study team will further explain the study to you and answer any questions that you may have.  You will be asked about your medical history and diabetes.  You may have a physical exam (if directed by the doctor) and blood and urine samples will be taken.  If qualified, you will be asked to attend several study visits which all require appointments at Northwestern Memorial Hospital in downtown Chicago approximately every six months over a period of five years and take a pill every day.