Focusing on the Menopausal Transition to Improve Mid-Life Women's Health

What this study is testing ClinicalTrials.gov NCT06975111 ↗

Description as written by the study sponsor.

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.

Treatments tested

• Metformin Drug

  Metformin will be given to participants who have a elevated HbA1c and also for weightloss.

• semaglutide Drug

  Overweight women and women with obesity will take Semaglutide for weight-loss

• Anti-hypertensives also known as The use of angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), a calcium channel blocker, or a thiazide diuretic. Drug

  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 also known as The use of generic statins Drug

  . 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 Behavioral

  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 Drug

  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 Drug

  Participants will be treated with estrogen and/or progesterone for treatment of hot flashes in women during the study.