Phase 4 N=41 Basic Science

Menopausal Sleep Fragmentation and Body Fat Gain

Menopause

Bottom Line

View on ClinicalTrials.gov: NCT03047330 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2024

Primary outcome: Primary: Normalized Serum Leptin Levels — 96.7; 94.0; 90.0; 101.0 percentage of mean baseline leptin — p=0.22

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Estradiol withdrawal (Drug); Fragmented sleep (Other)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Brigham and Women's Hospital
Primary completion: Aug 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Normalized Serum Leptin Levels	96.7; 94.0; 90.0; 101.0	0.22
SECONDARY Normalized Satiety Scores	99.2; 113.1; 102.6; 109.3	0.048 sig

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03047330). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.