Menopausal Sleep Fragmentation and Body Fat Gain



Status:Recruiting
Conditions:Insomnia Sleep Studies, Women's Studies
Therapuetic Areas:Psychiatry / Psychology, Reproductive
Healthy:No
Age Range:21 - 45
Updated:6/28/2018
Start Date:July 15, 2017
End Date:March 2021
Contact:Aleta Wiley, MPH
Email:awiley1@bwh.harvard.edu
Phone:6175259627

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Menopausal Sleep Fragmentation: Impact on Body Fat Gain Biomarkers in Women

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.

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.

Inclusion Criteria:

- Healthy premenopausal women 21-45 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
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