Omaha-area residents at high risk for developing Type 2 diabetes are needed for a large-scale clinical trial being conducted on the role of vitamin D in preventing or delaying the disease.
Researchers in Omaha need 150 participants to take part in a $40 million, five-year trial that is being conducted at 20 sites across the United States, including at the Omaha VA Medical Center and the University of Nebraska Medical Center. About 2,500 people nationwide will be recruited for the trial, which is funded by the National Institutes of Health.
The goal is to learn whether vitamin D — specifically, vitamin D3 — will keep adults age 30 or older with pre-diabetes from developing diabetes.
Some small studies have found that vitamin D may improve the functioning of beta cells, which produce insulin, said Dr. Cyrus Desouza, the trial's regional principal investigator, who is an endocrinologist at the Omaha VA Medical Center and chief of endocrinology at UNMC. “We get diabetes because (beta cells) slowly stop functioning,” he said.
Vitamin D also may reduce insulin resistance, he said. Researchers, Desouza said, will examine both beta-cell function and insulin resistance.
If vitamin D does keep blood glucose levels under control, he said, physicians and patients would have an inexpensive way to help prevent diabetes. Vitamin D supplements, Desouza said, cost pennies per day, while diabetes drugs are much more expensive.
A balanced, healthy diet and exercise remain the primary management tools for preventing diabetes, he said.
Half the participants in the trial will receive a daily dose of 4,000 international units of vitamin D. The other half will receive a placebo. Participants will have checkups for the study twice a year.
Desouza said all participants will be allowed to continue taking multivitamins containing up to 1,000 IUs of vitamin D, if they wish.
To learn if you are eligible to participate in the D2d study, call Penny Anzures at 402-995-3924 or email firstname.lastname@example.org.
Desouza also is principal investigator for a study being conducted at UNMC, the Omaha VA Medical Center and 36 other sites. That study is comparing the long-term benefits and risks of four widely used diabetes drugs in combination with metformin.
The five-year, $2.1 million study, also funded by the National Institutes of Health, is enrolling about 5,000 people nationwide. Participants must have been diagnosed with type 2 diabetes in the past five years and must be taking only metformin for their diabetes. During the study, participants will take metformin along with a second medication randomly assigned from among four classes of medications.
For the metformin study, contact Grace Rodriguez at UNMC at 402-559-6244 or Alissa Alfred at the VA Medical Center at 402-995-4121.