First Participant Identified for UNMC Study Seeking To Prevent or Delay Onset of Diabetes with Oral Insulin Treatment

A 7-year-old Lincoln boy is the first participant in a national diabetes study at the University of Nebraska Medical Center aimed at trying to prevent or delay the onset of diabetes in patients at risk for the disease.

The boy, Jacob Marvin, is the son of Duane and Rochelle Marvin of Lincoln. Duane Marvin has Type 1, insulin-dependent diabetes. Jacob qualified for the study after undergoing a series of tests which determined that he is moderately at risk to develop diabetes.

The tests found that Jacob has islet cell and insulin autoantibodies, which are indicators that a person is at risk for developing diabetes. In Jacob=s case, he has a 30 to 40 percent increased risk of developing diabetes in the next five years, said James Lane, M.D., an endocrinologist who is the principal investigator in the UNMC study.

Physicians from around the region have been screening relatives of people with Type 1 diabetes.  James Guest, M.D., Jacob’s physician in Lincoln, did the original screening on Jacob and referred him to the UNMC study.

Type 1 diabetes is a life-long disorder that can occur in children or adults. It occurs when the body attacks and destroys the insulin-producing cells in the pancreas. It’s estimated that 16 million Americans have diabetes. Of this number, about 10 to 15 percent have Type I diabetes. The rest have Type 2 diabetes. With Type 2 diabetes, the disease occurs later in life and develops more gradually.

Type 1 diabetes usually occurs early in life and demands a lifetime of balancing treatment, diet and activities to control the disease. If not controlled, Type 1 diabetes can lead to serious complications such as blindness, kidney failure, amputations and transplants.

The study is being conducted nationwide at more than 350 screening sites. UNMC is affiliated with the University of Minnesota, which is one of the nine centers heading the study.

"Although Jacob doesn’t have diabetes, his immune system is showing evidence for potential immune destruction of the beta cells which produce insulin," Dr. Lane said.

Since Feb. 17, Jacob has been participating in an oral insulin trial. In this double blind trial which lasts five years, patients will be given either an oral insulin capsule or a placebo each day at breakfast. Participants won’t know if they’re receiving insulin or the placebo.

"The purpose of the study is determine if insulin taken by mouth can desensitize the immune system and prevent the destruction of insulin-producing cells in the pancreas," Dr. Lane said. "The goal is not to lower blood sugar but rather to introduce insulin to the immune system.

"It’s very similar to what happens to people taking allergy shots. Once you find out what the allergy is, you try to counteract the allergy by giving the person increasing doses of what they are allergic to."

Participants in the study will come back every six months for studies of the insulin-producing cells in the pancreas. If participants should develop diabetes during the five-year study period, they reach the end of the study.

Dr. Lane said UNMC hopes to identify 10 patients for its portion of the study, which is limited to people at moderate risk of developing diabetes. Of the 579 patients screened to date in Nebraska, only about 3 percent of patients screened for the study have actually qualified for the moderate or high risk phases of the study. He stressed the importance of receiving referrals from physicians around the state in order to meet the study goal of 10 patients.

Participants in the study will receive all treatment and medications at no charge. For more information, people should call (402) 559-8176.

UNMC is the only public academic health science center in the state. Through its commitment to research, education and patient care, UNMC has established itself as one of the country’s leading centers for cancer research and treatment and solid organ transplantation. More than $34 million in research grants and contracts are awarded to UNMC scientists annually. In addition, UNMC’s educational programs are responsible for training more health professionals practicing in Nebraska than any other institution.