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Completed

NCT Number: NCT03047330

Menopausal Sleep Fragmentation and Body Fat Gain

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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Key information

Conditions

Menopause Body Weight Body Weight Changes Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Deprivation Sleep Wake Disorders Weight Gain

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Estradiol withdrawal

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.

Other names: Leuprolide Acetate; Lupron

Fragmented sleep

Other

Fragmented sleep will be experimentally induced.

Primary outcomes

  1. Normalized Serum Leptin Levels

    Time frame: pre/post sleep fragmentation (3 days); pre/post estradiol withdrawal (~5 weeks)

    12-hr overnight fasted AM (morning) blood samples were assayed for leptin levels on study days 2-6 under both estrogenized and estradiol-withdrawal conditions [total: 10 samples]. For each individual, leptin values were normalized relative to the mean baseline leptin value. Baseline was defined as the unfragmented estrogenized condition (avg. of study days 2-3 in the estrogenized condition).

Secondary outcomes

  1. Normalized Satiety Scores

    Time frame: pre/post sleep fragmentation (3 days); pre/post estradiol withdrawal (~5 weeks)

    12-hr overnight fasted AM satiety scores were collected on study days 2-6 under both estrogenized and estradiol-withdrawal conditions [total: 10 scores]. For each individual, satiety scores were normalized relative to the mean baseline satiety score. Baseline was defined as the unfragmented estrogenized condition (avg. of study days 2-3 in the estrogenized condition).

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Feb 8, 2017
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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