D2d Study Calling People with Prediabetes
Vitamin D is being studied for its potential role in preventing diabetes type 2. Are you at risk for the disease from having low vitamin D?
Over the years, many studies have explored the role of vitamin D in the prevention, development, and treatment of diabetes. Now a new large study called D2d (vitamin D and type 2 diabetes) is launching in an attempt to identify whether vitamin D can reduce the risk of developing this common disease, and the researchers are looking for people with prediabetes.
Do you qualify for D2d?
The clinical trial, which is funded by the National Institutes of Health and is a collaborative effort with the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), is recruiting now for the multiyear study. Participants must be aged 30 or older and meet two of the following three criteria, which are indications of prediabetes:
- Have a fasting plasma glucose of 100 to 125 mg/dL
- Have a two-hour plasma glucose of 140 to 199 mg/dL
- Have a hemoglobin A1 of 5.7 to 6.4 percent
Other criteria as well as exclusions apply, and you can see these on the clinical trial website. An estimated 2,500 individuals will be recruited.
About 20 locations throughout the United States are involved in the trial in the following states: Arizona, California, Florida, Georgia, Illinois, Kansas, Louisiana, Maine, Maryland, Massachusetts, Minnesota, Nebraska, New York, North Carolina, South Carolina, Tennessee, and Texas.
How the trial works
The trial is placebo-controlled and double-blinded, which means half of the participants will receive a placebo and the other half will be given 4,000 International Units of vitamin D3 (cholecalciferol) to be taken daily over the study period. Neither the participants nor the clinical professionals will know which subjects are taking the placebo or which are taking the vitamin.
Everyone who participates in the trial will be required to undergo a checkup twice a year and will also go to their own doctors for regular health care. The trial will continue until the number of participants who have developed type 2 diabetes reaches a value that allows the researchers to make a scientifically valid comparison between diabetes and no diabetes. This has been estimated to take four years.
Why is this trial important?
Previous research has indicated that vitamin D may be helpful in preventing type 2 diabetes, but results have not been conclusive. This is the first time investigators have explored whether 4,000 IUs of vitamin D can be beneficial in preventing the development of type 2 diabetes among people who have prediabetes.
Two things are known: the number of people in the United States with prediabetes or full-blown diabetes is staggering: about 79 million and 26 million, respectively. The other is that many people do not get enough vitamin D, a nutrient that has been shown to provide numerous health benefits.
According to Myrlene Staten, MD, the D2d project officer at NIDDK, “we need rigorous testing to determine if vitamin D will help prevent diabetes. That’s what D2d will do.”
You may have an opportunity to participate in a study that helps current and future cases of type 2 diabetes. If you have prediabetes and are interested in D2d, consult your doctor or visit the D2d website for additional information.
National Institutes of Health
Image: Wikimedia Commons