Clinical Trial Seeks to Save Beta Cells in Type 1 Diabetes
EPISODE #18
Uploaded: June 22, 2009
Running Time: 3:30
SCHMALFELDT: From the National Institutes of Health in Bethesda, Maryland, this is CLINICAL CENTER RADIO. Type 1 diabetes, formerly known as juvenile diabetes, happens when insulin-producing cells known as beta cells in the pancreas are attacked and destroyed by the body’s immune system. Insulin shots remain the best-known way to control blood sugars in folks with Type 1 diabetes. But is there a way to possibly reverse diabetes in humans by stimulating growth of new beta cells? That’s what researchers at the National Institute of Diabetes and Digestive and Kidney Diseases hope to learn as result of an ongoing clinical trial being conducted here at the NIH Clinical Center. Dr. David Harlan is the study’s principal investigator.
HARLAN: What we are really after is that we know that the more insulin an individual can make, the easier it is for them to control their blood sugar and we also know that the better control of blood sugar an individual maintains, the fewer complications they have. So what we are after is ease of blood glucose control and prevention of the complications of the disease.
SCHMALFELDT: The intent of the study is to attempt to preserve the remaining beta cells in a person’s pancreas so that they can continue to produce insulin by using a drug that has worked in studies on mice. They plan to enroll adults and adolescents who have been diagnosed in the past 4 months as having Type 1 diabetes. Once selected, they’ll be randomized to two different groups. Dr. Harlan explains.
HARLAN: We will be doing what is called a double blind randomized control trial, meaning that we are going to bring in 82 patients, half of whom will receive the active drug and half of whom will get sugar pills. And we won’t know who’s getting what and they won’t know who is getting what.
SCHMALFELDT: In addition to having been diagnosed in the last four months, participants must fall between the ages of 16 and 30. Dr. Mahfuzul Khan, lead associate investigator for the study, explained the reason for these restrictions.
KHAN: There are a lot of controversies in the diabetes research field as to whether an individual really can regenerate any insulin producing cells or not. It seems like the duration of diabetes has something to do with that capacity as well as the age of the individual at the time of diagnosis has something to do with that potential. The clinical trials that are being conducted nowadays primarily involve patients that have been diagnosed with Type 1 diabetes within three months. Based on that assumption, our sort of empirical evidence if you will, so that is why we are limiting to four months at the time of diagnosis.
SCHMALFELDT: If you would like more information about clinical trials, log on to http://clinicalcenter.nih.gov, or e-mail prpl@mail.cc.nih.gov. You may also call, toll free, 1-866-999-5553. From America's Clinical Research Hospital, this has been CLINICAL CENTER RADIO. In Bethesda, Maryland, I'm Bill Schmalfeldt at the National Institutes of Health, an agency of the United States Department of Health and Human Services.
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