Clinical Trial Will Study Whether Resting Insulin-Producing Cells in Adolescents and Young Adults with Type 2 Diabetes can Help Them Make Insulin

EPISODE #5
Uploaded:  November 17, 2008
Running Time:  4:52

SCHMALFELDT: From the National Institutes of Health in Bethesda, Maryland, this is CLINICAL CENTER RADIO.

People suffering from Type 2 diabetes typically have two underlying problems – they are unable to produce enough insulin – which allows the body to convert glucose into energy – and their bodies do not respond properly to the insulin that is being produced.  Scientists at the NIH Clinical Center are wondering if – by giving “beta cells,” the body’s insulin-producing cells in the pancreas, a brief vacation – they can help a patient with type 2 diabetes improve his or her ability to make insulin in the long term.  At the beginning of the study, all participants will be treated with an oral diabetes medicine called “metformin.”  Then they will be divided into two groups.  Group 1 will continue to take metformin and will follow a diet prescribed by a study dietician for two weeks.  Group 2 will also continue to take metformin and follow the prescribed diet.  In addition, they will receive insulin through a pump under the skin and take a drug called diazoxide by mouth for two weeks.  This causes the “beta cells” in the pancreas to temporarily shut down, since the body is getting the insulin it needs from an outside source.  All study participants will be hospitalized for two to four days and will have several diagnostic tests done, including blood sugar testing and oral glucose tolerance tests.  Afterwards, all participants will continue taking metformin.  Then they’ll be asked to return for a short outpatient visit every three months for the remainder of the yearlong study period.  Dr. Kristina Rother, a senior clinical investigator with the National Institute of Diabetes and Digestive and Kidney Diseases at the NIH, is the principal investigator for the study.

ROTHER:  What we hope to see is that a person who had trouble making enough insulin when the person comes to us will now make more insulin and that means, keep blood sugars under better control.  Unfortunately, in persons who have diabetes, beta cells gradually give up and work less well.  So there is sort of a downhill curve of beta cell function.  And if we could achieve that this curve doesn’t go down but stays straight, so beta cells work 12 months later as well as they worked at the onset of the study, that would also be a good result.

SCHMALFELDT: To be included for the study, participants must be between 12 and 25 years old, have been diagnosed with Type 2 diabetes and not currently be using insulin.  There are other inclusion and exclusion criteria as well.  Regardless of what the study shows after all the data is collected, Dr. Rother said there is one thing she can guarantee the people who take part in the study.  They will learn important facts about their diabetes.

ROTHER:  The one thing we can guarantee with this study is that patients, parents, families learn about diabetes.  Unfortunately in today’s very busy practices, most doctors don’t have much time to sit down with a patient and go over all the reasons, all the possible complications, the ways to prevent them, in the short period of time they have assigned for one patient.  The luxury we have at the NIH is to sit down with patients and really go over the entire story of diabetes, explaining why it happens, what we know about it.  And we feel that knowledge is power.  So if you know about your diabetes, you can control it.  It doesn’t control you.  That applies to any type of diabetes.

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 Episode One of 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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