Menopausal Sleep Fragmentation and Body Fat Gain

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-15

Study Completion Date

2022-08-01

Brief Summary

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This study aims to investigate the impact of menopause-related sleep fragmentation on metabolic biomarkers of body fat gain. The investigators hypothesize that experimental sleep fragmentation will result in an adverse leptin response as a metabolic biomarker for body fat gain.

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Detailed Description

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While obesity is highly prevalent in midlife and older women, with rates increasing markedly after age 40 and body fat increasing in half of women during and after the menopause transition, factors causing these changes are not well understood. Reduced total sleep time has been shown to adversely impact biomarkers of obesity, but the effect of the highly prevalent menopause-related sleep fragmentation secondary to hot flashes on metabolism and eating behaviors in humans is not known. We will use experimental paradigms to isolate the impact of menopause-related sleep disruption, as well as that of hot flashes and estrogen withdrawal, metabolic biomarkers of body fat gain and on eating behaviors, results of which will inform strategies to prevent body fat gain and improve cardio-metabolic health outcomes in women.

Conditions

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Menopause

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Study arm

Participants completed 2 nights of unfragmented sleep followed by 3 nights of experimentally-fragmented sleep during high estradiol (E2) phase of their menstrual cycle (Sleep Block 1). A subset of participants repeated these procedures in an experimentally-induced low-E2 state (Sleep Block 2).

Group Type EXPERIMENTAL

Estradiol withdrawal

Intervention Type DRUG

one injection of open-label intramuscular dose of leuprolide (3.75-mg depot), a gonadotropin-releasing hormone agonist that rapidly suppresses estradiol and temporarily achieves ovarian suppression.

Fragmented sleep

Intervention Type OTHER

Fragmented sleep will be experimentally induced.

Interventions

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Estradiol withdrawal

one injection of open-label intramuscular dose of leuprolide (3.75-mg depot), a gonadotropin-releasing hormone agonist that rapidly suppresses estradiol and temporarily achieves ovarian suppression.

Intervention Type DRUG

Fragmented sleep

Fragmented sleep will be experimentally induced.

Intervention Type OTHER

Other Intervention Names

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Leuprolide Acetate; Lupron

Eligibility Criteria

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Inclusion Criteria

* Healthy premenopausal women 18-45 years old
* Regular sleep schedule
* Limited alcohol and caffeine intake
* Regular monthly menstrual cycles
* No lifetime history of hot flashes
* Willingness to use approved methods of contraception during study
* Not obese
* Good general health

Exclusion Criteria

* Contraindication, hypersensitivity or previous adverse reaction to gonadotropin releasing hormone agonists
* Pregnancy
* Breastfeeding
* Tobacco use
* Contraindicated systemic hormone medications or centrally active medications
* Shift workers or recent/expected time zone travel
* Obstructive sleep apnea
* Insomnia symptoms
* Diagnosis of osteoporosis or osteopenia
* Hypothalamic-pituitary-adrenal axis disorders
* Diabetes
* Gastric bypass, metabolic disorders, or other related conditions
* Abnormalities on screening laboratory tests
* Substantial hearing impairment
* Cardiovascular illness
* Neurological illness
* Recent psychiatric illness or substance-use disorder

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes