A clinical UT Health San Antonio study on repurposing medications for age related diseases has selected roughly three participants for Rapamycin and Everolimus Study Towards Older Rejuvenation study two. The RESTOR study investigates a family of drugs, mTOR inhibitors, specifically rapamycin and everolimus. The two drugs are being tested for their role in slowing the aging process. In collaboration with Sam and Ann Barshop Institute for Longevity and Aging Studies, researchers collect data from RESTOR study two participants.
The study, called “Hemodynamic Resilience as a Target for Cardiometabolic Risk Stratification and Intervention in Older Adults,” aims to understand how type 2 diabetes and obesity contributes to aging and cardiovascular disease.
RESTOR study two participants partake in clinical trials through a routine schedule of interventions. These interventions may implement drugs, procedures or health practices.
Associate Professor Emeritus of Mathematics Sandy Norman is one of the subjects participating in RESTOR study two’s clinical trial. Norman is on a 42-day course of rapamycin, an immunosuppressant, to test its effectiveness and side effects. The trial is expected to last a year, and its objective is to find the optimal dosage of rapamycin.
From Norman’s experience conducting research as a mathematician, he knows it can be difficult to find participants. This was one of the reasons that motivated him to participate in the RESTOR study two clinical trials.
“I can imagine [for] studies in which people are getting poked with needles or taking drugs that are potentially harmful, it’s got to be really difficult to get people involved,” Norman said. “So after my retirement, I’d see if I could serve as a subject in various medical clinical trials.”
To qualify for RESTOR study two, participants have to be male or female, aged 65-90, in good health, agree to adhere to lifestyle considerations throughout the study and have the willingness to take the study medication as directed. Norman is 75 years old and met the other criteria to participate in the study.
When contemplating how the idea came about for this study, Norman explained previous responses to the medications.
“It appears that certain drugs that were being used for other purposes seem to be effective in dealing with cardiologic and diabetes effects,” Norman explained. “I think the particular drugs that they’re looking at have sort of immune response applications, so it’s an approach that hasn’t been used before.”
Norman detailed his experience taking a daily dosage of rapamycin for the past three weeks. No side effects have been documented yet from his dosage amount. So far, Norman has participated in physical tests, mental tests and two blood tests a week for RESTOR study two’s data collection on rapamycin.
Norman outlined the ethical protocols that the researchers put in place for the clinical trial involving human participants.
“They are very clear on the benefits of the study, but also on possible damages,” Norman explained. “Anyone that gets involved in the study can withdraw at any time, no penalties or anything like that. So ethically, I suppose people that are involved in the study sort of have the most complete information they need to make a choice about whether to participate or not, and they have the ability to leave at any point if they feel uncomfortable about what’s going on.”
The rapamycin dosages are distributed to the participants not to see how they benefit them in the study but how the drug can be utilized to help aging individuals’ immune systems in the future. Norman explained that taking rapamycin does not help with any health problems he has at the moment.
“They make it clear that there may be no direct benefit to me at all, but with any exploratory research, the benefit typically comes later,” Norman explained. “But it would never come at all without having these first steps taken.”
UT Health students are involved in the study as researchers and clinicians. As a participant, Norman explained the relationship between the subjects and researchers as friendly.
“I have to say that the staff that I’ve been involved with down there has been incredibly professional,” Norman emphasized. “They ‘re excited about being able to do something that might have some beneficial effects for people, mostly in the future, but they’re doing work that has to be done in order to make life better for folks.”
To find what clinical trials are in need of participants at UT Health San Antonio, visit barshopinstitute.uthscsa.edu.
