Clinical trial NCT03047330: Menopausal Sleep Fragmentation and Body Fat Gain
Official title: Menopausal Sleep Fragmentation: Impact on Body Fat Gain Biomarkers in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Menopause
Keywords: menopause
sleep fragmentation
leuprolide
adipokine
weight gain
leptin
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2017-02-08
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Normalized Serum Leptin Levels
timeFrame: pre/post sleep fragmentation (3 days); pre/post estradiol withdrawal (~5 weeks)
Secondary outcomes:
measure: Normalized Satiety Scores
timeFrame: pre/post sleep fragmentation (3 days); pre/post estradiol withdrawal (~5 weeks)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Hadine Joffe, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: