Focusing on the Menopausal Transition to Improve Mid-Life Women's Health
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Epigenetic aging measurements of "PhenoAge"
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Overweight Women
Women who fit in this category will receive medication for lowering insulin resistance and/or a weight loss medication.
干预措施: 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.
干预措施: Fezolinetant (Drug)
Preventative Health Advice
Participants will be given preventative health advice and asked to wear an activity & sleep monitor.
干预措施: Life style intervention (Behavioral)
Preventative Health Advice
Participants will be given preventative health advice and asked to wear an activity & sleep monitor.
干预措施: Hormonal therapy (Drug)
At Risk for Heart Disease
Medications will be given to each participant in this arm that lowers your heart disease risk.
干预措施: Anti-hypertensives (Drug)
At Risk for Heart Disease
Medications will be given to each participant in this arm that lowers your heart disease risk.
干预措施: 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.
干预措施: 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.
干预措施: Hormonal therapy (Drug)
Women with Obesity
Women that are over a BMI of 30 kg/m2 will be offered a GLP-1 antagonist.
干预措施: semaglutide (Drug)
Preventative Health Advice
Participants will be given preventative health advice and asked to wear an activity & sleep monitor.
干预措施: Fezolinetant (Drug)
At Risk for Heart Disease
Medications will be given to each participant in this arm that lowers your heart disease risk.
干预措施: Metformin (Drug)
Overweight Women
Women who fit in this category will receive medication for lowering insulin resistance and/or a weight loss medication.
干预措施: Metformin (Drug)
结局指标
主要结局
Epigenetic aging measurements of "PhenoAge"
时间窗: 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"
时间窗: Up to 2 years
Epigenetic aging, as assessed by GrimAge. GrimAge assesses lifespan from examining DNA Methylation.
次要结局
- 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)