Bioenergetic Effects of Aging and Menopause (BEAM)
The menopause transition is associated with increased risk for weight gain and a shift toward storing fat in the belly region, which may increase risk for cardiovascular disease and diabetes. The study will determine whether the stress hormone cortisol contributes to this shift.
Conditions:
🦠 Menopause 🦠 Obesity, Abdominal 🦠 Aging 🦠 Weight Gain
🗓️ Study Start (Actual) 24 September 2019
🗓️ Primary Completion (Estimated) 31 August 2024
✅ Study Completion (Estimated) 31 August 2024
👥 Enrollment (Estimated) 57
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 Aurora, Colorado, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • Volunteers will be healthy peri/postmenopausal women who are willing and able to undergo the proposed hormone manipulation and study procedures. Women will be at least 6 months but not more than 7 years past the last menstrual period (i.e., late perimenopausal or early postmenopausal) with FSH \>30 IU/L. We will make a major effort to ensure that the women enrolled in this study come from all races and ethnicities and a wide range of socioeconomic and educational levels. Women will be excluded for the reasons listed below.

    Exclusion Criteria:

    • * abnormal vaginal bleeding
    • * on hormonal contraceptive or menopausal therapy or intention to start during the period of study
    • * positive pregnancy test or intention to become pregnant during the period of study
    • * lactation
    • * known hypersensitivity to degarelix acetate, estradiol, or medroxyprogesterone acetate
    • * Center for Epidemiological Studies Depression Scale (CES-D) score \<,16 (unless clinician follow-up and clinical judgement determine they are eligible (will be noted in study chart)
    • * current tobacco and/or vape use more than 2 times/week
    • * current marijuana or tetrahydrocannabinol (THC) use in any form more than 3 times/week
    • * regular self-reported alcohol consumption \>14 drinks/week
    • * BMI \>39 kg/m2
    • * use of glucocorticoids or drugs that affect glucocorticoid metabolism (e.g., ketoconazole)
    • * severe osteopenia or osteoporosis, defined as femoral neck or lumbar spine t-score \<-2.0
    • * thyroid dysfunction, defined as an ultrasensitive TSH \<0.5 or \>5.0 mU/L; volunteers with abnormal thyroid stimulating hormone (TSH) values will be re-considered for participation in the study after follow-up evaluation by the PCP with initiation or adjustment of thyroid hormone replacement
    • * liver dysfunction, defined as liver function tests (AST, ALT) \>1.5 times the upper limit of normal
    • * uncontrolled hypertension defined as resting systolic BP \>150 mmHg or diastolic BP\>90 mmHg; participants who do not meet these criteria at first screening will be re-evaluated, including after follow-up evaluation by the primary care provider (PCP) with initiation or adjustment of anti-hypertensive medications
    • * self-reported history of breast cancer or other estrogen-dependent neoplasms
    • * self-reported history of venous thromboembolism, pulmonary embolism, or other thromboembolic disorder
    • * self-reported history of cardiovascular disease
Ages Eligible for Study: 40 Years to 65 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 25 June 2019
  • First Submitted that Met QC Criteria 31 July 2019
  • First Posted 2 August 2019

Study Record Updates

  • Last Update Submitted that Met QC Criteria 15 December 2023
  • Last Update Posted 18 December 2023
  • Last Verified December 2023