This study plans to learn more about what happens to women during the late menopause transition and use of dietary education, lifestyle modification and medication to improve health and quality of life. You are being asked to be in this study because you are a woman 45-55 years old and are in the late menopausal transition.
The leading cause of death in postmenopausal women is cardiovascular disease, and metabolic syndrome amplifies this risk. Waning ovarian function during the menopause transition is associated with significant, adverse changes in cardiovascular risk, body composition, sleep, mood, cognition and physical activity. LDL cholesterol, visceral fat and carotid intimal-medial thickness all increase with menopause, and the incidence of metabolic syndrome is permanently increased. Endothelial function, as measured by flow-mediated dilation (FMD), is a key indicator of cardiovascular health. Notably, menopause is associated with an approximate 50% reduction in FMD, as measured in the brachial artery, highlighting the significant impact of menopause on vascular function and cardiovascular wellness. All these changes are observed within a 2-4 year period that begins several years before a woman is menopausal. Yet interventions to treat aging women are usually recommended only after menopause has been defined, either by one year of amenorrhea or 6 months of amenorrhea accompanied by an elevated follicle stimulating hormone (FSH) level.
We are looking for women ages 45-55, in the late menopausal transition (defined as 60 days of amenorrhea but less than 365 days of amenorrhea), no current use of hormone therapy or hormonal contraception, presence of a uterus and at least one ovary in order to track menstrual patterns, and have a smartphone and broadband access adequate to accept telehealth appointments. Here are some common reasons for ineligiblity: Having a lack of broadband access (activity and survey data will be collected electronically whenever possible and some visits will be via telehealth), a lack of regular menstrual periods in mid-reproductive life (ages 25-38) when not on hormones or not pregnant, pregnant or actively trying to get pregnant, untreated alcoholism or substance use, undiagnosed abnormal uterine bleeding. We will not automatically exclude for any specific medical allergy or intolerance, because the treatment protocols that are planned are part of standard of care, will be administered by a physician, and if there is an individual reason why the first line agent(s) cannot be used, there are multiple alternatives. We will not automatically exclude for any hormone dependent cancers or other cancers because there are non-hormonal alternative treatments for vasomotor symptoms which will be used in such participants, administered by a physician and taking into account all modalities and patient factors in the choice of treatment. Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia (MEN 2) will be an exclusion for potential participants with a BMI > 30 because these individuals will be unable to take semaglutide, as it is contraindicated.
Protocol Number: 25-0943
Principal Investigator