Trial · Interventional

CompletedPhase 4Results postedRegistry data

Menopausal Sleep Fragmentation and Body Fat Gain

NCTNCT03047330Other id2016P002821Other id1R01AG053838

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 4
Enrollment: 41 participants (actual)
Sponsor: Brigham and Women's Hospital · Other
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
United States
Start: 15 Jul 2017
Primary completion: 1 Aug 2022
Completion: 1 Aug 2022
First posted: 8 Feb 2017 (estimated)
Last update posted: 8 Oct 2024
Conditions: Menopause

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2017201820192020202120222023

Ph 4
Menopausal Sleep Fragmentation and Body Fat Gain
NCT03047330
15 Jul 2017 to 1 Aug 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Estradiol withdrawalDrug
Fragmented sleepOther

Arms1

Experimental
Study arm
Participants completed 2 nights of unfragmented sleep followed by 3 nights of experimentally-fragmented sleep during high estradiol (E2) phase of their menstrual cycle (Sleep Block 1). A subset of participants repeated these procedures in an experimentally-induced low-E2 state (Sleep Block 2).

Primary outcomes1

Outcomes the sponsor listed as primary.

Normalized Serum Leptin Levels
Time frame · pre/post sleep fragmentation (3 days); pre/post estradiol withdrawal (~5 weeks)
Registry description
12-hr overnight fasted AM (morning) blood samples were assayed for leptin levels on study days 2-6 under both estrogenized and estradiol-withdrawal conditions \[total: 10 samples\]. For each individual, leptin values were normalized relative to the mean baseline leptin value. Baseline was defined as the unfragmented estrogenized condition (avg. of study days 2-3 in the estrogenized condition).

Secondary outcomes(1)

Normalized Satiety Scores
Time frame · pre/post sleep fragmentation (3 days); pre/post estradiol withdrawal (~5 weeks)
Registry description
12-hr overnight fasted AM satiety scores were collected on study days 2-6 under both estrogenized and estradiol-withdrawal conditions \[total: 10 scores\]. For each individual, satiety scores were normalized relative to the mean baseline satiety score. Baseline was defined as the unfragmented estrogenized condition (avg. of study days 2-3 in the estrogenized condition).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· pre/post sleep fragmentation (3 days); pre/post estradiol withdrawal (~5 weeks)

Normalized Serum Leptin Levels

Group	Value (percentage of mean baseline leptin)	Spread
Sleep Fragmentation - Active	96.7	2.5
Sleep Fragmentation - Control	94.0	1.5
Estradiol Withdrawal - Active	90.0	3.0
Estradiol Withdrawal - Control	101.0	1.1

Secondary and other outcome results(1)

Secondary outcomeMean· pre/post sleep fragmentation (3 days); pre/post estradiol withdrawal (~5 weeks)

Normalized Satiety Scores

Group	Value (percentage of mean baseline satiety)	Spread
Sleep Fragmentation - Active	99.2	11.9
Sleep Fragmentation - Control	113.1	11.0
Estradiol Withdrawal - Active	102.6	15.6
Estradiol Withdrawal - Control	109.3	7.8

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
All ParticipantsAll participants who initiated study procedures	0 / 41	0 / 41	32 / 41

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 45 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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

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