- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03047330
Menopausal Sleep Fragmentation and Body Fat Gain
August 23, 2023 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)
125
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
-
-
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: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sleep fragmentation - active
Participants after 3 nights of experimentally-fragmented sleep
|
Fragmented sleep will be experimentally induced.
|
No Intervention: Sleep fragmentation - control
Participants after 2 nights of unfragmented sleep
|
|
Experimental: Estradiol withdrawal - active
Participants after experimentally-induced hypo-estradiol
|
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:
|
No Intervention: Estradiol withdrawal - control
Participants during high-estradiol phase of menstrual cycle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Leptin
Time Frame: 12-hour overnight fasted morning sample
|
serum leptin levels
|
12-hour overnight fasted morning sample
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Satiety
Time Frame: 12-hour overnight fasted morning sample
|
subjective satiety measured by visual analog scale, 0 (low) - 100 (high)
|
12-hour overnight fasted morning sample
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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)
August 24, 2023
Last Update Submitted That Met QC Criteria
August 23, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Dyssomnias
- Sleep Wake Disorders
- Neurologic Manifestations
- Sleep Deprivation
- Physiological Effects of Drugs
- Antineoplastic Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Estrogens
- Reproductive Control Agents
- Fertility Agents, Female
- Fertility Agents
- Leuprolide
- Estradiol
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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