NCT04043520

Bioenergetic Effects of Aging and Menopause (BEAM)

Bioenergetic and Metabolic Consequences of the Loss of Ovarian Function in Women - 2018

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 57 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: Female
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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 stress hormone cortisol is known to promote the accumulation of belly fat, and there is evidence that low estrogen is associated with higher cortisol levels. The first aim of the study is to determine whether low estrogen levels in premenopausal and early postmenopausal women increase cortisol levels in the blood and in fat tissue. When estrogen level decreases at the time of menopause, there is an increase in follicle-stimulating hormone, or FSH. Recent evidence in mice suggests that blocking FSH prevents the increase in belly fat. The second aim of the study is to determine whether decreasing the high FSH level in postmenopausal women causes a decrease in belly fat and changes other factors that are typically thought to be related to estrogen rather than FSH. Because estrogen and FSH levels fluctuate in premenopausal and early postmenopausal women, the investigators will use an approach that controls estrogen and FSH levels to address the aims. The investigators will use a drug that is typically used to treat endometriosis or uterine fibroids to reduce estrogen and FSH levels and an estrogen patch to increase estrogen in some women. The study will generate new knowledge on how menopause affects fat gain and disease risk.

Conditions

• Menopause
• Obesity, Abdominal
• Aging
• Weight Gain

Interventions

Type	Name	Description
DRUG	GnRH antagonist	GnRH antagonist will be given once for premenopausal women (12-week intervention) and twice for postmenopausal women (24-week intervention)
DRUG	Estrogen Product	Estrogen patches will be worn by those randomized to the Estradiol arms in both premenopausal and postmenopausal groups. Patches will be applied weekly and will be worn for the for entirety of the intervention (12 or 24 weeks).
DRUG	Placebo estradiol	Placebo patches will be worn by those randomized to the placebo arms in both premenopausal and postmenopausal groups. Patches will be applied weekly and will be worn for the for entirety of the intervention (12 or 24 weeks).
DRUG	Placebo GnRH antagonist	Postmenopausal women randomized to the placebo injection arm will receive two placebo drug injections of normal saline (24-week intervention)

Timeline

• Start date: 2019-09-24
• Primary completion: 2024-08-31
• Completion: 2024-08-31
• First posted: 2019-08-02
• Last updated: 2023-12-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study