Menopausal Sleep Fragmentation and Body Fat Gain

Menopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03047330
• Other study ID #: 2016P002821
• Secondary ID: 1R01AG053838
• Status: Completed
• Phase: Phase 4
• Start date: July 15, 2017
• Est. completion date: August 1, 2022

Study information

• Verified date: August 2023
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: August 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Menopause
• Sleep Deprivation

Intervention

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:
• Fragmented sleep
Fragmented sleep will be experimentally induced.

Locations

Country	Name	City	State
United States	Brigham & Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Leptin	serum leptin levels	12-hour overnight fasted morning sample
Secondary	Satiety	subjective satiety measured by visual analog scale, 0 (low) - 100 (high)	12-hour overnight fasted morning sample