Are changes in cardiovascular disease risk factors in midlife women due to chronological aging or to the menopausal transition?
Karen A Matthews, Sybil L Crawford, Claudia U Chae...
https://pubmed.ncbi.nlm.nih.gov/20082925/Actively Recruiting
Led by University of Colorado, Denver · Updated on 2026-07-21
200
Participants Needed
3
Research Sites
47 weeks
Total Duration
Researchers are evaluating a range of health interventions for midlife women aged 45 to 55 who are in the late menopausal transition. This study aims to reduce menopause-related inflammation, improve heart and metabolic health, reverse biological aging markers, and lessen menopausal symptoms. The goal is to help these women lower their risk of future diseases, enhance quality of life, and increase their healthspan and productivity. Participants will be assigned to different groups based on their health risks and symptoms. One group receives preventative health advice and wears a device to monitor activity and sleep. Other groups receive medications to lower heart disease risk, improve insulin resistance, support weight loss, or reduce hot flashes with hormone therapy or non-hormonal drugs like neurokinin receptor antagonists. Treatments include drugs such as metformin, semaglutide, antihypertensives, statins, hormonal therapy, and Fezolinetant. Advice on lifestyle factors like diet, physical activity, and alcohol intake is also provided. During the study, participants undergo assessments including epigenetic aging measurements up to two years, blood tests for inflammatory markers, surveys on menopausal quality of life, and monitoring of blood vessel health. Researchers track adherence through electronic data collection and telehealth visits. Safety and symptom improvements are followed for up to two years to evaluate the impact of these interventions on womens health during menopause.
CONDITIONS
Focusing on the Menopausal Transition to Improve Mid-Life Women's Health
C
Carrie Hsu, BA
N
Nalia Naushad
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University of Colorado, Denver
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Preventative Health Advice | At Risk for Heart Disease | Overweight, Obesity, or Hot Flashes |
|---|---|---|---|
| What it is | Women assigned to the preventative advice group receive lifestyle guidance based on current cardiovascular and menopause guidelines, such as encouragement of healthy BMI, physical activity, salt moderation, and limiting alcohol. They are also provided with a wearable activity monitor. | Women identified as at risk for heart disease, based on clinical evaluation, are treated according to primary prevention guidelines, which includes the use of antihypertensive medication for hypertension (ACE inhibitors, ARBs, calcium channel blockers, or thiazide diuretics) and statins for lipid lowering as appropriate. | Women who are overweight, have obesity, or experience menopausal hot flashes receive interventions tailored to their clinical need: semaglutide or metformin for weight loss, hormone therapy (estrogen and/or progesterone) or fezolinetant for hot flashes. |
| Primary use | To promote healthy aging and reduce future cardiovascular and metabolic risk by supporting lifestyle changes in midlife women in the menopausal transition. | To reduce cardiovascular risk factors in women identified as at higher risk by managing blood pressure and lipid levels according to guideline-based targets. | To address menopause-associated symptoms and metabolic risk factors, such as hot flashes and excess weight, through evidence-based pharmacologic therapy or hormonal therapy as appropriate. |
| How it is given or performed | Participants receive lifestyle advice during clinic or telehealth visits and use a wearable activity monitor to support daily activity tracking. | Participants receive antihypertensive or statin medication as needed per clinical guidelines, with ongoing monitoring of blood pressure, lipids, and adherence. | Participants receive medications at clinic visits or as prescribed: semaglutide or metformin as oral agents for weight/metabolic risk, hormone therapy as oral or transdermal agents, and fezolinetant (neurokinin receptor antagonist) for hot flashes. |
| Evidence status | Lifestyle interventions are recommended by current guidelines and supported by observational and interventional studies for reducing cardiovascular and metabolic disease risk in midlife women. | Antihypertensive and lipid-lowering therapy are recommended interventions for high-risk women, with strong evidence for reducing cardiovascular events and improving outcomes, as summarized in guidelines and published trials. | Hormone therapy and neurokinin receptor antagonists are guideline-recommended for menopausal symptoms in appropriate candidates; metformin and semaglutide have strong supporting evidence for metabolic benefit and weight loss. |
| Important limitations | Lifestyle interventions require motivation, adherence, and ongoing support. Effects on clinical outcomes can be influenced by participant engagement, social support, and environmental barriers. | Medication adherence and potential side effects such as statin intolerance or antihypertensive-related symptoms may limit impact. Not all cardiovascular risk can be eliminated with medication therapy alone. | Pharmacologic treatment for weight or menopausal symptoms may have contraindications and is not suitable for every candidate. Side effects, drug availability, and patient preferences may limit use or success. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 2 years
Participants receive health advice, wear an activity and sleep monitor, and may take medications to lower heart disease risk, improve insulin resistance, support weight loss, or reduce hot flashes depending on their group.
Regular visits and telehealth appointments
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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https://pubmed.ncbi.nlm.nih.gov/33470142/University of Colorado, Denver
Lead Sponsor