Print

Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 45 Years and 55 Years
Eligible Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Participants will be placed into treatment interventions based on their health and screening tests.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Preventative Health Advice 		Participants will be given preventative health advice and asked to wear an activity & sleep monitor.
  • Behavioral: 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.
  • Drug: 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.
  • Drug: Hormonal therapy
    Participants will be treated with estrogen and/or progesterone for treatment of hot flashes in women during the study.
Active Comparator
At Risk for Heart Disease 		Medications will be given to each participant in this arm that lowers your heart disease risk.
  • Drug: Metformin
    Metformin will be given to participants who have a elevated HbA1c and also for weightloss.
  • Drug: 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.
    Other names:
    • The use of angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), a calcium channel blocker, or a thiazide diuretic.
  • Drug: 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.
    Other names:
    • The use of generic statins
  • Behavioral: 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.
Active Comparator
Overweight Women 		Women who fit in this category will receive medication for lowering insulin resistance and/or a weight loss medication.
  • Drug: Metformin
    Metformin will be given to participants who have a elevated HbA1c and also for weightloss.
  • Drug: semaglutide
    Overweight women and women with obesity will take Semaglutide for weight-loss
Active Comparator
Women with Obesity 		Women that are over a BMI of 30 kg/m2 will be offered a GLP-1 antagonist.
  • Drug: semaglutide
    Overweight women and women with obesity will take Semaglutide for weight-loss
Active Comparator
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.
  • Drug: 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.
  • Drug: Hormonal therapy
    Participants will be treated with estrogen and/or progesterone for treatment of hot flashes in women during the study.

Recruiting Locations

University of Colorado-School of Medicine
Aurora, Colorado 80045

More Details

Status
Recruiting
Sponsor
University of Colorado, Denver

Study Contact

Carrie Hsu, BA
303-724-5276
carrie.hsu@cuanschutz.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.