Menopausal Sleep Fragmentation and Body Fat Gain
Primary Purpose
Menopause
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Estradiol withdrawal
Fragmented sleep
Sponsored by
About this trial
This is an interventional basic science trial for Menopause focused on measuring menopause, sleep fragmentation, leuprolide, adipokine, weight gain, leptin
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
Sites / Locations
- Brigham & Women's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
No Intervention
Experimental
No Intervention
Arm Label
Sleep fragmentation - active
Sleep fragmentation - control
Estradiol withdrawal - active
Estradiol withdrawal - control
Arm Description
Participants after 3 nights of experimentally-fragmented sleep
Participants after 2 nights of unfragmented sleep
Participants after experimentally-induced hypo-estradiol
Participants during high-estradiol phase of menstrual cycle
Outcomes
Primary Outcome Measures
Leptin
serum leptin levels
Secondary Outcome Measures
Satiety
subjective satiety measured by visual analog scale, 0 (low) - 100 (high)
Full Information
NCT ID
NCT03047330
First Posted
February 7, 2017
Last Updated
August 23, 2023
Sponsor
Brigham and Women's Hospital
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT03047330
Brief Title
Menopausal Sleep Fragmentation and Body Fat Gain
Official Title
Menopausal Sleep Fragmentation: Impact on Body Fat Gain Biomarkers in Women
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
July 15, 2017 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
August 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menopause
Keywords
menopause, sleep fragmentation, leuprolide, adipokine, weight gain, leptin
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
125 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sleep fragmentation - active
Arm Type
Experimental
Arm Description
Participants after 3 nights of experimentally-fragmented sleep
Arm Title
Sleep fragmentation - control
Arm Type
No Intervention
Arm Description
Participants after 2 nights of unfragmented sleep
Arm Title
Estradiol withdrawal - active
Arm Type
Experimental
Arm Description
Participants after experimentally-induced hypo-estradiol
Arm Title
Estradiol withdrawal - control
Arm Type
No Intervention
Arm Description
Participants during high-estradiol phase of menstrual cycle
Intervention Type
Drug
Intervention Name(s)
Estradiol withdrawal
Other Intervention Name(s)
Leuprolide Acetate; Lupron
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Fragmented sleep
Intervention Description
Fragmented sleep will be experimentally induced.
Primary Outcome Measure Information:
Title
Leptin
Description
serum leptin levels
Time Frame
12-hour overnight fasted morning sample
Secondary Outcome Measure Information:
Title
Satiety
Description
subjective satiety measured by visual analog scale, 0 (low) - 100 (high)
Time Frame
12-hour overnight fasted morning sample
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hadine Joffe, MD MSc
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
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Menopausal Sleep Fragmentation and Body Fat Gain
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