Overview
As people age, the risk for developing chronic diseases and conditions increases. The FDA approved drugs rapamycin (sirolimus) and rapamycin analogs (everolimus) increase the quality and quantity of lifespan in animals. It remains unknown if the same could be true for humans. The purpose of this research study is to learn if the rapamycin analog everolimus can help improve or maintain the health and function of adults 55-80 years old who may have insulin resistance or pre-diabetes. As a part of this study, you will be asked to take low doses of everolimus or placebo once daily and once weekly for 24-weeks. There will be several assessments before, during and after the 24 weeks. These include blood and muscle sampling, and measurements of body composition, metabolism, exercise capacity (VO2max), and brain and heart health. All visits are located at the University of Wisconsin- Madison campus and you will be compensated up to $2000 for your time.
You May Qualify to Participate if you meet the following:
- Are between the ages of 55-80 years old
- Are not taking medications to lower glucose or that prolong bleeding
- Have pre-diabetes or insulin resistance, but are otherwise healthy
- This would include an elevated fasting glucose (100-125 mg/dL) or HbA1c (5.7-6.4%). If you do not know if you have values consistent with pre-diabetes or insulin resistance, we can help determine this for you at no cost.
Participants Will:
- Take a pill once daily and once weekly for 24 weeks
- Be monitored by physicians and study team before, during, and after the course of the study
- Complete a variety of health tests as shown in the Study Schematic below.
- These include exercise testing, blood and muscle sampling, heart and brain imaging, glucose testing and continuous glucose monitoring (CGM), and a body composition scan (DEXA Scan)
- You will be compensated up to $2000 for your time!
Study Schematic
Potential Risks from Study Drug: We are commonly asked about potential risks associated with the everolimus. Like all medications, there are risks of side effects with everolimus and certain medicines that you should not take with everolimus. We will review your current medications (if applicable) to determine your potential eligibility and review the details of potential side effects to ensure that you can make an informed decision on whether to participate or not. Briefly, most side effects are related to the dose used. For patients who need everolimus, it is prescribed at relatively high doses (1.5 to 10 mg per day). Our study uses lower doses (0.5 mg once per day or 5 mg once per week) to help minimize the most common risks.
Please contact our study team if you are interested in learning more about the study details or if you have questions:
Email is generally not a secure way to communicate sensitive or health related information as there are many ways for unauthorized users to access email. You should avoid sending sensitive, detailed personal information by email. Email should also not be used to convey information of an urgent nature. If you need to talk to someone immediately or would prefer not to receive study communication by email, please contact the EVERLAST study team at 608-228-2978.