Focusing on the Menopausal Transition to Improve Mid-Life Women's Health
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 200
- Locations
- 3
- Primary Endpoint
- Epigenetic aging measurements of "PhenoAge"
Study Overview
Brief Summary
What if midlife women, who are inherently at an increased risk for future cardiometabolic disease due to transitioning into menopause, had access to a suite of evidence-based health interventions? Could these interventions reduce menopause-related inflammation, restore a healthier cardiometabolic profile, reverse epigenetic aging, and reduce bothersome menopausal symptoms? The ultimate goal of this work is to attenuate future disease and enhance women's quality of life, extend healthspan and increase productivity.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to 55 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •aged 45-55
- •In the late menopausal transition, defined as 60 days of amenorrhea but less than 365 days of amenorrhea18
- •No current use of hormone therapy or hormonal contraception
- •Presence of a uterus and at least one ovary in order to track menstrual patterns
- •Have a smartphone and broadband access adequate to accept telehealth appointments
Exclusion Criteria
- •Lack of broadband access (activity and survey data will be collected electronically whenever possible and some visits will be via telehealth)
- •Lack of regular menstrual periods in mid-reproductive life (ages 25-38) when not on hormones or not pregnant.
- •Pregnancy or actively trying to get pregnant
- •Inability to adhere to study protocol schedule
- •Untreated alcoholism
- •Un- Diagnosed abnormal uterine bleeding
- •Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia (MEN 2) for participants with a BMI> 30 kg/m2.
Arms & Interventions
Overweight Women
Women who fit in this category will receive medication for lowering insulin resistance and/or a weight loss medication.
Intervention: semaglutide (Drug)
Women With Hot Flashes
Women with Hot flashes will have either hormonal or non-hormonal medication to reduce the number and/or severity of hot flashes.
Intervention: Fezolinetant (Drug)
Preventative Health Advice
Participants will be given preventative health advice and asked to wear an activity & sleep monitor.
Intervention: Life style intervention (Behavioral)
Preventative Health Advice
Participants will be given preventative health advice and asked to wear an activity & sleep monitor.
Intervention: Hormonal therapy (Drug)
At Risk for Heart Disease
Medications will be given to each participant in this arm that lowers your heart disease risk.
Intervention: Anti-hypertensives (Drug)
At Risk for Heart Disease
Medications will be given to each participant in this arm that lowers your heart disease risk.
Intervention: Lipid Lowering Medication (Drug)
At Risk for Heart Disease
Medications will be given to each participant in this arm that lowers your heart disease risk.
Intervention: Life style intervention (Behavioral)
Women With Hot Flashes
Women with Hot flashes will have either hormonal or non-hormonal medication to reduce the number and/or severity of hot flashes.
Intervention: Hormonal therapy (Drug)
Women with Obesity
Women that are over a BMI of 30 kg/m2 will be offered a GLP-1 antagonist.
Intervention: semaglutide (Drug)
Preventative Health Advice
Participants will be given preventative health advice and asked to wear an activity & sleep monitor.
Intervention: Fezolinetant (Drug)
At Risk for Heart Disease
Medications will be given to each participant in this arm that lowers your heart disease risk.
Intervention: Metformin (Drug)
Overweight Women
Women who fit in this category will receive medication for lowering insulin resistance and/or a weight loss medication.
Intervention: Metformin (Drug)
Outcomes
Primary Outcomes
Epigenetic aging measurements of "PhenoAge"
Time Frame: Up to 2 years
Change in epigenetic aging, as assessed by PhenoAge. PhenoAge calculates a biological age score based on key biomarkers circulating in the bloodstream. A lower PhenoAge score suggests slower biological aging, while a higher score indicates accelerated aging.
Epigenetic aging measurements of "GrimAge"
Time Frame: Up to 2 years
Epigenetic aging, as assessed by GrimAge. GrimAge assesses lifespan from examining DNA Methylation.
Secondary Outcomes
- IL-1(Up to 2 years)
- TNF-alpha(Up to 2 years)
- IL-6(Up to 2 years)
- IL-8(Up to 2 years)
- Flow-mediated dilation(Up to 2 years)
- Serum Marker for Ovarian Aging(Up to 2 years)
- MENQOL survey(Up to 2 years)
- Eaotoxin levels(Up to 2 years)