Focusing on the Menopausal Transition to Improve Mid-Life Women's Health
- Conditions
- MenopauseMenopause Hot FlashesMenopause Related ConditionsCardiovascular
- Interventions
- Behavioral: Life style interventionDrug: Anti-hypertensivesDrug: Hormonal therapyDrug: Lipid Lowering Medication
- Registration Number
- NCT06975111
- Lead Sponsor
- University of Colorado, Denver
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 200
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Preventative Health Advice Life style intervention Participants will be given preventative health advice and asked to wear an activity \& sleep monitor. Preventative Health Advice Fezolinetant Participants will be given preventative health advice and asked to wear an activity \& sleep monitor. Preventative Health Advice Hormonal therapy Participants will be given preventative health advice and asked to wear an activity \& sleep monitor. At Risk for Heart Disease Metformin Medications will be given to each participant in this arm that lowers your heart disease risk. At Risk for Heart Disease Anti-hypertensives Medications will be given to each participant in this arm that lowers your heart disease risk. At Risk for Heart Disease Lipid Lowering Medication Medications will be given to each participant in this arm that lowers your heart disease risk. At Risk for Heart Disease Life style intervention Medications will be given to each participant in this arm that lowers your heart disease risk. Overweight Women Metformin Women who fit in this category will receive medication for lowering insulin resistance and/or a weight loss medication. Overweight Women semaglutide Women who fit in this category will receive medication for lowering insulin resistance and/or a weight loss medication. Women with Obesity semaglutide Women that are over a BMI of 30 kg/m2 will be offered a GLP-1 antagonist. Women With Hot Flashes Fezolinetant Women with Hot flashes will have either hormonal or non-hormonal medication to reduce the number and/or severity of hot flashes. Women With Hot Flashes Hormonal therapy Women with Hot flashes will have either hormonal or non-hormonal medication to reduce the number and/or severity of hot flashes.
- Primary Outcome Measures
Name Time Method Epigenetic aging measurements of "PhenoAge" 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" Up to 2 years Epigenetic aging, as assessed by GrimAge. GrimAge assesses lifespan from examining DNA Methylation.
- Secondary Outcome Measures
Name Time Method IL-1 Up to 2 years Inflammatory IL-1 serum levels, examined to determine a person's inflammatory state. Higher levels of IL-1 can indicate more inflammation. Being in an "inflamed state" can have detrimental effects on a woman's health.
TNF-alpha Up to 2 years Serum inflammatory marker TNF-alpha. Higher levels of TNF-alpha can indicate more inflammation. TNF-alpha is examined to determine a person's inflammatory state.
IL-6 Up to 2 years Serum IL-6 levels. IL-6 is examined to determine a person's inflammatory state. Higher levels of IL-6 indicate more inflammation. Being in an "inflamed state" can have detrimental effects on a women's health.
IL-8 Up to 2 years IL-8 serum levels. IL-8 is examined to determine a person's inflammatory state. Higher levelf of IL-8 indicate more inflammation. Being in an "inflamed state" can have detrimental effects on a women's health.
Flow-mediated dilation Up to 2 years Flow-mediated dilation measures the diameter of vascular and endothelial cell function and predicts cardiovascular event risk. The diameter of the target artery is measured by high-resolution external vascular ultrasound in response to an increase in blood flow.
Serum Marker for Ovarian Aging Up to 2 years Anti-mullerian hormones (AMH) serum levels will be analyzed. AMH is an indicator of ovarian aging and reflects egg supply. Lower levels of AMH indicate a lower egg supply.
MENQOL survey Up to 2 years Menopause-specific Quality of Life (MENQOL) measures quality of life in menopausal women. It is self-administered and consists of a total of 29 items in a Likert-scale format. Each item assesses the impact of one of four domains of menopausal symptoms, as experienced over the last month: vasomotor, psychosocial, physical, and sexual. There will be a overall score and we are examining if there is a change in response to treatment.
Eaotoxin levels Up to 2 years Eaotoxin is a inflammatory marker that increases when there is an inflammed state in a woman. Serum Eaotoxin will be measured before, during and at the end of the study.
Trial Locations
- Locations (1)
University of Colorado-School of Medicine
🇺🇸Aurora, Colorado, United States