Focusing on the Menopausal Transition to Improve Mid-Life Women's Health
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
Age45-55
SponsorUniversity of Colorado, Denver
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Metformin
DrugMetformin will be given to participants who have a elevated HbA1c and also for weightloss.
semaglutide
DrugOverweight women and women with obesity will take Semaglutide for weight-loss
Anti-hypertensives
Druga. 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
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
Behavioralwill 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
DrugWomen 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
DrugParticipants will be treated with estrogen and/or progesterone for treatment of hot flashes in women during the study.
Treatment groups
200 Participants
are divided into 5 treatment groupsGroup A: Preventative Health AdviceExperimental treatment 3 interventions
Group B: At Risk for Heart DiseaseActive comparator 4 interventions
Group C: Overweight WomenActive comparator 2 interventions
Group D: Women with ObesityActive comparator 1 intervention
Group E: Women With Hot FlashesActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Epigenetic aging measurements of "PhenoAge"
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.
Time frame
Up to 2 years2
Epigenetic aging measurements of "GrimAge"
Epigenetic aging, as assessed by GrimAge. GrimAge assesses lifespan from examining DNA Methylation.
Time frame
Up to 2 yearsSecondary outcomes
1
IL-1
Inflammatory IL-1 serum levels, examined to determine a person's inflammatory state. Higher levels of IL-1 can indicate more inflammation. Being in an "inflamed state" can have detrimental effects on a woman's health.
Time frame
Up to 2 years2
TNF-alpha
Serum inflammatory marker TNF-alpha. Higher levels of TNF-alpha can indicate more inflammation. TNF-alpha is examined to determine a person's inflammatory state.
Time frame
Up to 2 years3
IL-6
Serum IL-6 levels. IL-6 is examined to determine a person's inflammatory state. Higher levels of IL-6 indicate more inflammation. Being in an "inflamed state" can have detrimental effects on a women's health.
Time frame
Up to 2 years4
IL-8
IL-8 serum levels. IL-8 is examined to determine a person's inflammatory state. Higher levelf of IL-8 indicate more inflammation. Being in an "inflamed state" can have detrimental effects on a women's health.
Time frame
Up to 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov