Study of Hormone Changes and Belly Fat in Women During Menopause Transition

What this Trial Is About

The menopause transition is linked to weight gain and a shift toward storing fat in the belly, which may raise the risk of cardiovascular disease and diabetes. Researchers are exploring whether the stress hormone cortisol contributes to this fat distribution change. The study focuses on women in late perimenopause or early postmenopause, examining how changes in estrogen and follicle-stimulating hormone FSH levels affect cortisol and fat accumulation. Participants will be assigned to one of three groups one receiving a GnRH antagonist drug called degarelix acetate plus an estradiol patch, another receiving the GnRH antagonist plus a placebo patch, and a third group receiving placebo injections and placebo patches. The GnRH antagonist is given by subcutaneous injection twice, at baseline and 12 weeks, while patches are applied weekly for 24 weeks. This approach controls estrogen and FSH levels to study their impact on belly fat and related factors. Throughout the study, participants undergo various assessments including blood and fat tissue tests to measure cortisol, body scans to evaluate fat area, bone density measurements, and tests of energy use and blood vessel function. These measurements occur at baseline, 12 weeks, and 24 weeks. The primary outcomes focus on changes in cortisol response at 12 weeks. The study includes close monitoring of participants health and hormone levels during the intervention period, which lasts up to 24 weeks.

Bioenergetic Effects of Aging and Menopause (BEAM)