Menopausal Sleep Fragmentation and Body Fat Gain

September 17, 2024 updated by: Hadine Joffe, MD MSc, Brigham and Women's Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham & Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Other: Fragmented sleep
Fragmented sleep will be experimentally induced.
Drug: 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.
Other Names:
  • Leuprolide Acetate; Lupron

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
pre/post sleep fragmentation (3 days); pre/post estradiol withdrawal (~5 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
pre/post sleep fragmentation (3 days); pre/post estradiol withdrawal (~5 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Hadine Joffe, MD MSc, Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2017

Primary Completion (Actual)

August 1, 2022

Study Completion (Actual)

August 1, 2022

Study Registration Dates

First Submitted

February 7, 2017

First Submitted That Met QC Criteria

February 7, 2017

First Posted (Estimated)

February 8, 2017

Study Record Updates

Last Update Posted (Actual)

October 8, 2024

Last Update Submitted That Met QC Criteria

September 17, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016P002821
  • 1R01AG053838 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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