The purpose of this research is to learn how the loss of estrogen changes metabolism and risk of disease in women. At the time of menopause there are changes to body composition and metabolism that may lead to an increase in the risk of chronic disease. Why this happens is not known, but it is thought to be related to the loss of estrogen. Women in this study will receive 6 monthly injections that contain either placebo (no active drug) or a study drug (leuprolide) that reduces estrogen to postmenopausal levels. During the 6 months of treatment, some women will also participate in a supervised exercise program and some will not. Participants randomized into the “no exercise” group will have the opportunity to take part in the exercise program after completing the study.
The main inclusion criteria for this study include:
- Healthy women aged 40 to 60 years
- Regular menstrual cycles
- No current use of hormonal contraceptives
Benefits for study volunteers include:
- Measurement of body composition and bone density
- Fitness testing
- Personalized and supervised exercise program
Frequently Asked Questions Regarding the FAME Study:
- What will I be paid for participating in this study? The compensation for finishing this study is $900. If the study is not completed for any reason, compensation is provided at $80 for each of the 6 monthly drug injections, and up to $140 for completing each of the 3 testing phases.
- Where do I go for study testing? All of our testing will be on the Anschutz Medical Campus (Fitzsimons Campus) in Aurora.
- How long will I be in this study? Participating in the FAME study should take approximately 1 year from the start of the screening process until the completion of the study.
- What are the benefits I will receive from this study? The FAME study will allow you to learn more about your current health including your bone density, percent body fat, aerobic fitness, resting metabolic rate, and routine blood tests. You will also receive exercise training either during or after the research study.
- Why would I want my hormones suppressed? The Lupron injections will give you a reversible preview into what menopause will be like. This will let you understand how to deal with some of the symptoms that your mothers, sisters, co-workers, and friends may be going through. Because the menopause may put women at risk for osteoporosis, diabetes, and heart disease, learning more about your current health status and understanding the importance of an active lifestyle will be an invaluable tool for dealing with menopause when that time comes for you.
For more information on the FAME study please contact Kim Harner at 720-848-6399 or Kimberly.Harner@ucdenver.edu. The Principal Investigator of the FAME study is Wendy Kohrt, PhD. This study is funded by the National Institutes of Health and has been approved by the Colorado Multiple Institutional Review Board (protocol #12-1157).