Bioenergetic Effects of Aging and Menopause (BEAM)

Launched by UNIVERSITY OF COLORADO, DENVER · Jul 31, 2019

Keywords

ClinConnect Summary

The Bioenergetic Effects of Aging and Menopause (BEAM) study is looking into how menopause affects weight gain, especially in the belly area, which can lead to health issues like heart disease and diabetes. Researchers want to find out if the stress hormone cortisol plays a role in this change. The trial is currently recruiting healthy women who are either going through menopause or have recently completed it—specifically, those who are between 6 months to 7 years past their last menstrual period.

To participate, women must be willing to undergo some hormone-related procedures and be in good health. They should not be taking hormonal treatments or have certain health conditions, such as severe osteoporosis or high blood pressure. Participants can expect to engage in various study activities aimed at understanding how menopause affects their body. This study aims to include women from diverse backgrounds, ensuring a broad representation in the research. If you think you might qualify, it could be a valuable opportunity to contribute to important health research.

Gender

FEMALE

Eligibility criteria

• 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