175 with prediabetes needed for medications study
175 area residents with a diagnosis of prediabetes are encouraged to enroll in a clinical trial offered by UT Health San Antonio and University Health System. The study, conducted at the Texas Diabetes Institute (TDI), is comparing four medications to see which will best prevent conversion to Type 2 diabetes.
“People with prediabetes are at very high risk of progressing to overt diabetes,” said Alberto Chavez, MD, who sees patients at the TDI and is leading the clinical trial. “We believe they should be treated, but which therapy to use is presently unclear.”
Researchers will divide study enrollees into four groups, and each group will be treated with a specific medication. The medications are approved by the U.S. Food and Drug Administration for the treatment of people with diabetes and are proven to be safe and effective.
There are preliminary studies that indicate these therapies are effective in prediabetes, Dr. Chavez said.
The medications under evaluation are:
- Dapagliflozin, which is called a SLGT-2 inhibitor
- Saxagliptin, which is called a DPP-4 inhibitor
Patients will be randomly assigned to one of these therapies and treated for 30 months with periodic checkups at the TDI.
“Everyone is going to benefit,” Dr. Chavez said. “We know that all these medicines work to some extent in people with diabetes. Now we want to know which one will work the best to spare people from developing diabetes at all.”
The time to prevent diabetes is now. Diabetes and other underlying conditions increase the likelihood of hospitalization from COVID-19. People with diabetes have a three times higher risk, according to the U.S. Centers for Disease Control and Prevention.
Study participants will periodically undergo a glucose tolerance test to measure insulin sensitivity and beta cell function, which are important indicators of diabetes risk.
Enrollees must be 18 to 65 and have a body mass index score between 24 and 40. Anyone already taking a diabetes medicine or who has a diagnosis of diabetes is not eligible.
The doctors have an idea which of the medications work the best and will put their hypothesis to the test.
“In this study, the gold standard drug is metformin,” Dr. Chavez said. “But we are pretty sure pioglitazone will beat metformin, and we also believe that the SGLT-2 inhibitor, dapagliflozin, will beat metformin. And we think the DPP-4 inhibitor, saxagliptin, will be about the same as metformin.”
Millions of people take these medicines, said study senior investigator Ralph DeFronzo, MD, professor of medicine in the Joe R. and Teresa Lozano Long School of Medicine at UT Health San Antonio. Dr. DeFronzo is chief of the diabetes division and deputy director of the TDI.
Metformin is prescribed for 45% of diabetes patients, DPP-4 inhibitors for about 30%, SGLT-2 inhibitors for about 12% and pioglitazone for about 3%, according to recent data, Dr. DeFronzo said.
Eligible individuals are invited to call the Texas Diabetes Institute clinical trials line at (210) 358-7200. This study is funded by the National Institutes of Health.
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The Long School of Medicine at The University of Texas Health Science Center at San Antonio is named for Texas philanthropists Joe R. and Teresa Lozano Long. The school is the largest educator of physicians in South Texas, many of whom remain in San Antonio and the region to practice medicine. The school teaches more than 900 students and trains 800 residents each year. As a beacon of multicultural sensitivity, the school annually exceeds the national medical school average of Hispanic students enrolled. The school’s clinical practice is the largest multidisciplinary medical group in South Texas with 850 physicians in more than 100 specialties. The school has a highly productive research enterprise where world leaders in Alzheimer’s disease, diabetes, cancer, aging, heart disease, kidney disease and many other fields are translating molecular discoveries into new therapies. The Long School of Medicine is home to a National Cancer Institute-designated cancer center known for prolific clinical trials and drug development programs, as well as a world-renowned center for aging and related diseases.
The University of Texas Health Science Center at San Antonio, also referred to as UT Health San Antonio, is one of the country’s leading health sciences universities and is designated as a Hispanic-Serving Institution by the U.S. Department of Education. With missions of teaching, research, patient care and community engagement, its schools of medicine, nursing, dentistry, health professions and graduate biomedical sciences have graduated more than 37,000 alumni who are leading change, advancing their fields, and renewing hope for patients and their families throughout South Texas and the world. To learn about the many ways “We make lives better®,” visit www.uthscsa.edu.
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