Aging Clinical Trial
— BEAMOfficial title:
Bioenergetic and Metabolic Consequences of the Loss of Ovarian Function in Women - 2018
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.
Status | Recruiting |
Enrollment | 57 |
Est. completion date | August 31, 2024 |
Est. primary completion date | August 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 40 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado - Anschutz Medical Campus | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver | National Institute on Aging (NIA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in the Microdialysis Cortisone Challenge (MCC) Index | The MCC Index is an in vivo measurement of local cortisol production in abdominal adipose tissue. A higher MCC Index is an indicator of more local cortisol production. | Baseline, week 12 | |
Primary | Change in the Oral Cortisone Challenge (OCC) Area Under the Curve (AUC) | The OCC AUC is a systemic measurement of peripheral glucocorticoid metabolism. A higher OCC AUC is an indicator of more production of cortisol. | Baseline, week 12 | |
Secondary | Change in lumbar spine Bone Mineral Density (BMD) | Lumbar spine BMD is measured by dual-energy x-ray absorptiometry. A higher BMD is a general indicator of less risk for osteoporosis. | Baseline, week 24 | |
Secondary | Change in resting energy expenditure (REE) | REE is an index of metabolic rate at rest, measured by indirect calorimetry. A higher REE is an indicator of greater energy expenditure at rest. | Baseline, week 12, week 24 | |
Secondary | Change in visceral fat area (VFA) | VFA of the abdominal visceral region is measured by computed tomography. VFA is an indicator of the amount of fat stored in this region. | Baseline, week 24 | |
Secondary | Change in flow-mediated dilation (FMD) | FMD of the brachial artery as an index of vascular function. A higher number is a general indicator of better vascular function. | Baseline, week 12, week 24 | |
Secondary | Change in proximal femur Bone Mineral Density (BMD) | Proximal femur BMD is measured by dual-energy x-ray absorptiometry. A higher BMD is a general indicator of less risk for osteoporosis. | Baseline, week 24 |
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