Sleep DisturbanceSLEEP-INNCT04286451
Effect of Sleep Restriction on Adipose Tissue and Skeletal Muscle Insulin Sensitivity
A study testing Sleep Restriction and Habitual Sleep in people with Sleep Disturbance and Postmenopausal Symptoms, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
Inadequate sleep is an independent risk factor for metabolic abnormalities (such as obesity, insulin resistance, and hyperglycemia). Women report sleep disruption during the menopause transition (perimenopause) and into the postmenopausal years. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Disturbance, Postmenopausal Symptoms, Insulin Sensitivity
- What is being tested?
- Sleep Restriction and Habitual Sleep
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2020to 13 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Body mass index (BMI) 25-35 kg/m2 (inclusive)
- Postmenopausal (self-reported absence of menstrual cycle for 1-year)
- Within 10 years of final menstrual cycle
- Self-reported nocturnal time in bed of ≥6.5 hours per night (for ≥5 nights during a usual week)
- Willing to not take naps or engage in moderate-to-vigorous physical activity/exercise during both sleep conditions
- Willing to consume only the meals provided during both sleep conditions
- Willing to have adipose tissue and skeletal muscle biopsies
- Willing to have blood, as well as adipose and muscle tissue stored for future use
Who cannot join
- Unstable weight in the last 3 months [gain or loss ≥5% of body weight]
- History of clinically diagnosed diabetes or a fasting blood glucose >126 mg/dL
- History of polycystic ovary syndrome (PCOS)
- Currently taking antihypertension medication known to affect adipose tissue and skeletal muscle metabolism (e.g., diuretics may be allowed)
- Chronic use of systemic glucocorticoids
- Chronic use of atypical antipsychotic or bipolar medications
Show all 17Show fewer
- Initiation of antidepressant medication within the last 3 months
- Previous bariatric surgery (or other surgeries) for obesity or weight loss
- Chronic use of prescription or 'effective' over-the-counter medications affecting sleep, circadian rhythms, or glucose metabolism †
- Chronic use of hormone replacement therapy
- History of clinically diagnosed sleep apnea
- Shift workers (e.g., individuals awake or working between Midnight and 5AM)
- Inability to spend 5 nights at Pennington Biomedical
- Unwilling to eat only the food and drink provided by study staff while in the study
- Unwilling to maintain a consistent and prescribed sleep schedule while in the study
- Unwilling to maintain a consistent eating schedule while in the study
- Sporadic use of certain medications is fine (however, enrollment will depend on a case-by-case basis). If taking sporadically, women should not be taking the medication for 1-month prior to the first Run-In period.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Inadequate sleep is an independent risk factor for metabolic abnormalities (such as obesity, insulin resistance, and hyperglycemia). Women report sleep disruption during the menopause transition (perimenopause) and into the postmenopausal years. Sleep disruption is one of the primary reasons why midlife women seek medical care, with up to 60% reporting significant sleep disturbances (e.g., trouble falling asleep, early morning waking, and hot flashes/night sweats). Despite the majority of women experiencing sleep disruption, no study has investigated the molecular mechanisms linking sleep disruption and the changes in metabolism that coincide with menopause.
Read the detailed description
The investigators will conduct a randomized, crossover trial investigating the effect of sleep restriction compared to habitual sleep on adipose tissue and skeletal muscle insulin sensitivity in vivo and ex vivo. The investigators will randomize up to 10 healthy postmenopausal women with overweight/obesity and ≥6.5 hours of self-reported habitual nightly sleep to 4 nights of each sleep condition (sleep restriction and habitual sleep). After the fourth night of each sleep condition, the investigators will administer a two-step hyperinsulinemic-euglycemic clamp and collect skeletal muscle and adipose tissue samples prior to insulin infusion.
The overarching hypothesis is that sleep restriction will reduce skeletal muscle and adipose tissue insulin sensitivity compared to habitual sleep.
- Conditions
- Sleep Disturbance, Postmenopausal Symptoms, Insulin Sensitivity, Cardiovascular Risk Factor
- Being tested
- Sleep Restriction, Habitual Sleep
- Medical subject headings
- Parasomnias, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep RestrictionBehavioural
Women will be undergo 4 nights of sleep restriction.
Habitual SleepBehavioural
Women will be undergo 4 nights of habitual sleep.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Restriction | Experimental | Women will undergo 4 nights of sleep restriction treatment. Receives: Behavioral: Sleep Restriction |
| Habitual Sleep | Experimental | Women will undergo 4 nights of habitual sleep treatment. Receives: Behavioral: Habitual Sleep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose infusion rate (via 2-step hyperinsulinemic-euglycemic clamp) (in vivo)
Insulin sensitivity by a 2-step hyperinsulinemic euglycemic clamp is performed at the end sleep conditions.
Measured: 4 days
Secondary outcomes (9)
Adipose tissue insulin sensitivity (via free fatty acid area-under-the-curve during the low-dose clamp) (in vivo)
During the low-dose insulin portion of the hyperinsulinemic-euglycemic clamp, free fatty acids will be samples across a 3-hour period to quantify a surrogate measure of adipose tissue insulin sensitivity in vivo.
Measured: 4 days
Insulin-dependent suppression of lipolysis (via ex vivo adipose tissue biopsy analyses)
Release of free fatty acids and glycerol in culture.
Measured: 4 days
Fat oxidation and substrate switching (via ex vivo skeletal muscle biopsy analyses)
Using primary myotubes, fat oxidation and substrate switching will be tested by measuring [1-14C]palmitate oxidation ± varying levels of glucose and pyruvate
Measured: 4 days
Insulin sensitivity (via ex vivo skeletal muscle biopsy analyses)
Myotubes will be incubated ± insulin (100nM) in media containing: [U-14C]-glucose to measure glucose oxidation and glycogen synthesis; [3H]-2-deoxyglucose to assess glucose uptake; or unlabeled DMEM to test insulin signaling (western blot)
Measured: 4 days
Gene expression (via ex vivo skeletal muscle biopsy analyses with RNASeq and RT-PCR)
Genes related to oxphos and circadian clock regulators will be assessed by RNASeq and confirmed with RT-PCR.
Measured: 4 days
Glucose Area-Under-The-Curve (via 2-hour standard meal test)
Glucose area-under-the-curve (AUC) will be calculated throughout a 2-hour period following consumption of a standard meal (dinner shake) test on Day 4 of each sleep condition.
Measured: 4 days
Insulin Area-Under-The-Curve (via 2-hour standard meal test)
Insulin area-under-the-curve (AUC) will be calculated throughout a 2-hour period following consumption of a standard meal (dinner shake) test on Day 4 of each sleep condition.
Measured: 4 days
Blood pressure (via 24-hour ambulatory blood pressure monitoring)
Blood pressure monitoring will be performed for a 24-hour period during Day 3 of each sleep conditions.
Measured: 24 hours
Resting metabolic rate (via indirect calorimetry)
O2 consumption and CO2 production will be measured by indirect calorimetry for 40 min (last 30 min will be used for calculations) using a metabolic cart. Resting metabolic rate will be derived using standard equations.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start28 Jul 2020
- Primary completion13 Apr 2022
- Study completion13 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prachi Singh, Pennington Biomedical Research Center
- Investigators
- Kara L Marlatt, PhD, MPH, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04286451
- Sponsor's protocol ID
- PBRC 2020-007
- Acronym
- SLEEP-IN
- Status last verified
- Nov 2022
- First submitted
- 13 Jan 2020
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Suryadevara HNSK, Hebert RC, Staszkiewicz J, Ravussin E, Marlatt KL, Singh P, Ghosh S. Transcriptional remodeling of human skeletal muscle following sleep restriction in postmenopausal women. Physiol Genomics. 2026 May 1;58(5):225-238. doi: 10.1152/physiolgenomics.00269.2025. Epub 2026 Mar 28.
PubMed 41902670Singh P, Beyl RA, Stephens JM, Noland RC, Richard AJ, Boudreau A, Hebert RC, Ravussin E, Broussard JL, St-Onge MP, Marlatt KL. Effect of sleep restriction on insulin sensitivity and energy metabolism in postmenopausal women: A randomized crossover trial. Obesity (Silver Spring). 2023 May;31(5):1204-1215. doi: 10.1002/oby.23739. Epub 2023 Mar 30.
PubMed 36998155
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sleep Restriction on Adipose Tissue and Skeletal Muscle Insulin Sensitivity
- ClinicalTrials.gov ID
- NCT04286451
- Acronym / sponsor ID
- SLEEP-IN / PBRC 2020-007
- Conditions
- Sleep Disturbance, Postmenopausal Symptoms, Insulin Sensitivity, Cardiovascular Risk Factor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- 28 Jul 2020 (actual)
- Primary completion
- 13 Apr 2022 (actual)
- Study completion
- 13 Apr 2022 (actual)
- First posted
- 27 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Inadequate sleep is an independent risk factor for metabolic abnormalities (such as obesity, insulin resistance, and hyperglycemia). Women report sleep disruption during the menopause transition (perimenopause) and into the postmenopausal years. Sleep disruption is one of the primary reasons why midlife women seek medical care, with up to 60% reporting significant sleep disturbances (e.g., trouble falling asleep, early morning waking, and hot flashes/night sweats). Despite the majority of women experiencing sleep disruption, no study has investigated the molecular mechanisms linking sleep disruption and the changes in metabolism that coincide with menopause.
Detailed description
The investigators will conduct a randomized, crossover trial investigating the effect of sleep restriction compared to habitual sleep on adipose tissue and skeletal muscle insulin sensitivity in vivo and ex vivo. The investigators will randomize up to 10 healthy postmenopausal women with overweight/obesity and ≥6.5 hours of self-reported habitual nightly sleep to 4 nights of each sleep condition (sleep restriction and habitual sleep). After the fourth night of each sleep condition, the investigators will administer a two-step hyperinsulinemic-euglycemic clamp and collect skeletal muscle and adipose tissue samples prior to insulin infusion.
The overarching hypothesis is that sleep restriction will reduce skeletal muscle and adipose tissue insulin sensitivity compared to habitual sleep.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep Restriction | Experimental | Behavioral: Sleep RestrictionWomen will undergo 4 nights of sleep restriction treatment. |
| Habitual Sleep | Experimental | Behavioral: Habitual SleepWomen will undergo 4 nights of habitual sleep treatment. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Body mass index (BMI) 25-35 kg/m2 (inclusive)
- Postmenopausal (self-reported absence of menstrual cycle for 1-year)
- Within 10 years of final menstrual cycle
- Self-reported nocturnal time in bed of ≥6.5 hours per night (for ≥5 nights during a usual week)
- Willing to not take naps or engage in moderate-to-vigorous physical activity/exercise during both sleep conditions
Key exclusion criteria (17 listed)
- Unstable weight in the last 3 months [gain or loss ≥5% of body weight]
- History of clinically diagnosed diabetes or a fasting blood glucose >126 mg/dL
- History of polycystic ovary syndrome (PCOS)
- Currently taking antihypertension medication known to affect adipose tissue and skeletal muscle metabolism (e.g., diuretics may be allowed)
- Chronic use of systemic glucocorticoids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep RestrictionWomen will be undergo 4 nights of sleep restriction. | Behavioural | Sleep Restriction |
| Habitual SleepWomen will be undergo 4 nights of habitual sleep. | Behavioural | Habitual Sleep |
Primary outcome
Glucose infusion rate (via 2-step hyperinsulinemic-euglycemic clamp) (in vivo)
Time frame: 4 days
Insulin sensitivity by a 2-step hyperinsulinemic euglycemic clamp is performed at the end sleep conditions.
9 secondary outcomes
Adipose tissue insulin sensitivity (via free fatty acid area-under-the-curve during the low-dose clamp) (in vivo)
Time frame: 4 days
Insulin-dependent suppression of lipolysis (via ex vivo adipose tissue biopsy analyses)
Time frame: 4 days
Fat oxidation and substrate switching (via ex vivo skeletal muscle biopsy analyses)
Time frame: 4 days
Insulin sensitivity (via ex vivo skeletal muscle biopsy analyses)
Time frame: 4 days
Gene expression (via ex vivo skeletal muscle biopsy analyses with RNASeq and RT-PCR)
Time frame: 4 days
Glucose Area-Under-The-Curve (via 2-hour standard meal test)
Time frame: 4 days
Insulin Area-Under-The-Curve (via 2-hour standard meal test)
Time frame: 4 days
Blood pressure (via 24-hour ambulatory blood pressure monitoring)
Time frame: 24 hours
Resting metabolic rate (via indirect calorimetry)
Time frame: 4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
- Derived from this study: PubMed 41902670Suryadevara HNSK, Hebert RC, Staszkiewicz J, Ravussin E, Marlatt KL, Singh P, Ghosh S. Transcriptional remodeling of human skeletal muscle following sleep restriction in postmenopausal women. Physiol Genomics. 2026 May 1;58(5):225-238. doi: 10.1152/physiolgenomics.00269.2025. Epub 2026 Mar 28.
- Derived from this study: PubMed 36998155Singh P, Beyl RA, Stephens JM, Noland RC, Richard AJ, Boudreau A, Hebert RC, Ravussin E, Broussard JL, St-Onge MP, Marlatt KL. Effect of sleep restriction on insulin sensitivity and energy metabolism in postmenopausal women: A randomized crossover trial. Obesity (Silver Spring). 2023 May;31(5):1204-1215. doi: 10.1002/oby.23739. Epub 2023 Mar 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kara L Marlatt, PhD, MPH principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Restriction and Habitual Sleep in people with Sleep Disturbance and Postmenopausal Symptoms, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose infusion rate (via 2-step hyperinsulinemic-euglycemic clamp) (in vivo) (time frame: 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04286451, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2022.