Phase 4
Completed N=41
Menopausal Sleep Fragmentation and Body Fat Gain
Source: ClinicalTrials.gov NCT03047330 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcomePrimary: Normalized Serum Leptin Levels — 96.7; 94.0; 90.0; 101.0 percentage of mean baseline leptin — p=0.22
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 |
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
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. Informational only — not medical advice.