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Focusing on the Menopausal Transition to Improve Mid-Life Women's Health
Sponsor: University of Colorado, Denver
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.
Key Details
Gender
FEMALE
Age Range
45 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2026-03-01
Completion Date
2030-10-01
Last Updated
2026-03-09
Healthy Volunteers
Yes
Interventions
Metformin
Metformin will be given to participants who have a elevated HbA1c and also for weightloss.
semaglutide
Overweight women and women with obesity will take Semaglutide for weight-loss
Anti-hypertensives
a. Antihypertensives, with the goal of maintaining blood pressure at 130/80 or lower per ACC guidelines19. Per current clinical guidelines and standard of care, hypertension will be treated first with monotherapy using either an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), a calcium channel blocker, or a thiazide diuretic provided that are no contraindications.
Lipid Lowering Medication
. First line agents will be generic statin medications (atorvastatin or rosuvastatin)whichever is covered by the participant's health insurance), barring contraindication to their use.
Life style intervention
will simply be followed and given preventive advice (maintenance of a normal BMI and physical activity, moderation in salt intake, and no more than 1 alcoholic drink per day). They will be provided with a wearable activity monitor. This advice will be based on guidelines by the American Heart Association and the Menopause Society.
Fezolinetant
Women with menopausal symptoms will be treated with hormone therapy (estrogen and progesterone) if appropriate, or with a neurokinin receptor antagonist (Fezolinetant). This can be treatment for women in any arm of the study as well as an arm by its self.
Hormonal therapy
Participants will be treated with estrogen and/or progesterone for treatment of hot flashes in women during the study.
Locations (1)
University of Colorado-School of Medicine
Aurora, Colorado, United States