Trial · Interventional
RecruitingPhase 4Registry dataBioenergetic Effects of Aging and Menopause (BEAM)
Short name BEAM
Overview
- Status
- Recruiting
- Phase
- Phase 4
- Enrollment
- 57 participants (estimated)
- Sponsor
- University of Colorado, Denver · Other
- Design
- Randomized · Triple masking
- Countries
1 country
United States
- Start
- 24 Sept 2019
- Primary completion
- 31 Aug 2024 (estimated)
- Completion
- 31 Aug 2024 (estimated)
- First posted
- 2 Aug 2019
- Last update posted
- 18 Dec 2023
- Conditions
- Menopause · Obesity, Abdominal · Aging · Weight Gain
Timeline
1 trial · 1 ongoing
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 4
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- GnRH antagonistDrug
- Estrogen ProductDrug
- Placebo estradiolDrug
- Placebo GnRH antagonistDrug
Arms3
Experimental
Postmenopausal: GnRH antagonist + estradiol
GnRH antagonist is degarelix acetate, 80 mg, delivered twice as a subcutaneous injection (at baseline and after 12 weeks) Estradiol is a transdermal patch 0.075 mg, applied weekly for 24 weeks
Experimental
Postmenopausal: GnRH antagonist + placebo
GnRH antagonist is degarelix acetate, 80 mg, delivered twice as a subcutaneous injection (at baseline and after 12 weeks) Placebo is a transdermal patch, applied weekly for 24 weeks
Placebo comparator
Postmenopausal: placebo + placebo
Placebo (1) is normal saline, delivered twice as a subcutaneous injection (at baseline and after 12 weeks) Placebo (2) is a transdermal patch, applied weekly for 24 weeks
Primary outcomes2
Outcomes the sponsor listed as primary.
Change in the Microdialysis Cortisone Challenge (MCC) Index
Time frame · Baseline, week 12
Registry description
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.
Change in the Oral Cortisone Challenge (OCC) Area Under the Curve (AUC)
Time frame · Baseline, week 12
Registry description
The OCC AUC is a systemic measurement of peripheral glucocorticoid metabolism. A higher OCC AUC is an indicator of more production of cortisol.
Secondary outcomes(5)
Change in lumbar spine Bone Mineral Density (BMD)
Time frame · Baseline, week 24
Registry description
Lumbar spine BMD is measured by dual-energy x-ray absorptiometry. A higher BMD is a general indicator of less risk for osteoporosis.
Change in resting energy expenditure (REE)
Time frame · Baseline, week 12, week 24
Registry description
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.
Change in visceral fat area (VFA)
Time frame · Baseline, week 24
Registry description
VFA of the abdominal visceral region is measured by computed tomography. VFA is an indicator of the amount of fat stored in this region.
Change in flow-mediated dilation (FMD)
Time frame · Baseline, week 12, week 24
Registry description
FMD of the brachial artery as an index of vascular function. A higher number is a general indicator of better vascular function.
Change in proximal femur Bone Mineral Density (BMD)
Time frame · Baseline, week 24
Registry description
Proximal femur BMD is measured by dual-energy x-ray absorptiometry. A higher BMD is a general indicator of less risk for osteoporosis.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 40 Years up to 65 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
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