Insulin ResistanceNCT03594994
Metabolic Effects of Sleep Extension in People With Obesity
A study testing Sleep extension in people with Insulin Resistance and Obesity, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This study is designed to determine the impact of extending sleep duration on glucose metabolism in people with obesity. Half of the participants will be instructed to increase their time-in-bed in order to achieve >7h sleep/night (sleep extension; n=15) while the other half will be be instructed to maintain their… Read more about this study
- Who is it for?
- Ages 21 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Obesity
- What is being tested?
- Sleep extension
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2018to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sleep <7h/night
- Body mass index 25-50 kg/m2
- Altered glucose metabolism (any of the following) Fasting glucose 100-125 mg/dL or, 2-h plasma glucose 140-199 mg/dL during an oral glucose tolerance test (OGTT) or, HbA1c 5.7-6.4% or, homeostatic model assessment of insulin resistance (HOMA-IR) ≥2.0
Who cannot join
- Sleep disorders
- moderate to severe sleep apnea (apnea-hypopnea index ≥15 events/hour)
- had ≥15 periodic limb movements per hour sleep [PLMS]
- narcolepsy or insomnia
- Perform shift work
- Excessive caffeine or alcohol consumption
Show all 14Show fewer
- Significant organ dysfunction/disease (e.g. diabetes mellitus, kidney disease)
- Liver disease other than metabolic dysfunction associated steatotic liver disease (MASLD)
- Prior bariatric surgery
- Pregnancy or breastfeeding
- Taking medications that can affect study outcomes (alter sleep duration or glucose metabolism)
- Tobacco or illicit drug use
- Perform intense exercise >70 min/wk or moderate exercise >150 min/week
- Excessive alcohol consumption (>21 units of alcohol per week for men and >14 units of alcohol per week for women)
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
This study is designed to determine the impact of extending sleep duration on glucose metabolism in people with obesity. Half of the participants will be instructed to increase their time-in-bed in order to achieve >7h sleep/night (sleep extension; n=15) while the other half will be be instructed to maintain their current sleep habits (n=15).
Read the detailed description
Restricting sleep is known to be detrimental to glucose metabolism in healthy adults. Obesity is a condition associated with both lower sleep duration and poor glucose tolerance. Therefore, increasing sleep duration is a potentially novel therapeutic strategy for improving glucose metabolism in this population. The investigators will assess this by determining insulin sensitivity during a hyperinsulinemic-euglycemic clamp before and after a sleep intervention in both the control and sleep extension groups.
- Conditions
- Insulin Resistance, Obesity
- Being tested
- Sleep extension
- Medical subject headings
- Insulin Resistance, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep extensionBehavioural
Extend time-in-bed by one hour
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Maintain their usual sleep patterns |
| Sleep Extension | Experimental | Extend sleep duration to >7h/night; 15 participants Receives: Behavioral: Sleep extension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Sensitivity
Whole-body insulin sensitivity calculated as the insulin stimulated rate of glucose disposal per kilogram of fat-free body mass (µmol/kgFFM/min) during a hyperinsulinemic-euglycemic clamp.
Measured: Change from baseline testing after 4-6 weeks of intervention
Secondary outcomes (17)
Hepatic Insulin Sensitivity Index
Calculated as the inverse of the product of plasma insulin concentration and endogenous glucose rate of appearance (Ra)/kgFFM during the basal period of the clamp procedure. Higher values indicate greater insulin sensitivity.
Measured: Change from baseline testing after 4-6 weeks of intervention
Adipose Tissue Insulin Sensitivity Index
Calculated as the reciprocal of the product of palmitate Ra/kgFFM and plasma insulin concentration during basal conditions. Higher values indicate greater insulin sensitivity.
Measured: Change from baseline testing after 4-6 weeks of intervention
Homeostatic Model Assessment of Insulin Resistance
The homeostasis model assessment of insulin resistance (HOMA-IR) was calculated by dividing the product of the plasma concentrations of insulin (in µU/mL) and glucose (in mmol/L) by 22.5. Higher values indicate greater insulin resistance.
Measured: Change from baseline testing after 4-6 weeks of intervention
24 Hour Glucose Area Under the Concentration Curve
Plasma metabolite concentrations will be evaluated over a 24 hour period
Measured: Change from baseline testing after 4-6 weeks of intervention
24 Hour Insulin Area Under the Concentration Curve
Plasma insulin concentrations evaluated over a 24 hour period
Measured: Change from baseline testing after 4-6 weeks of intervention
24 Hour Non-esterified Fatty Acids Area Under the Concentration Curve
Plasma metabolite concentrations will be evaluated over a 24 hour period
Measured: Change from baseline testing after 4-6 weeks of intervention
Body Mass
Measured using a body weight scale
Measured: Change from baseline testing after 4-6 weeks of intervention
Fat-free Mass
Body composition assessed using dual-energy x-ray absorptiometry (DXA)
Measured: Change from baseline testing after 4-6 weeks of intervention
Body Fat
Body composition assessed using dual-energy x-ray absorptiometry (DXA)
Measured: Change from baseline testing after 4-6 weeks of intervention
Liver Fat
Proton-density fat fraction of the whole liver assessed by using magnetic resonance imaging (MRI)
Measured: Change from baseline testing after 4-6 weeks of intervention
Fasting Glucose
Plasma glucose measured after an overnight fast
Measured: Change from baseline testing after 4-6 weeks of intervention
Daily Time in Bed
Assessed by using actigraphy over 7 days
Measured: Change from baseline testing after 4-6 weeks of intervention
Daily Total Sleep Time
Assessed by using actigraphy over 7 days
Measured: Change from baseline testing after 4-6 weeks of intervention
Stage N1 Sleep Time
Assessed by using inpatient polysomnography
Measured: Change from baseline testing after 4-6 weeks of intervention
Stage N2 Sleep Time
Assessed by using inpatient polysomnography
Measured: Change from baseline testing after 4-6 weeks of intervention
Stage N3 Sleep Time
Assessed by using inpatient polysomnography
Measured: Change from baseline testing after 4-6 weeks of intervention
Rapid Eye Movement (REM) Sleep Time
Assessed by using inpatient polysomnography
Measured: Change from baseline testing after 4-6 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start29 Oct 2018
- Primary completion15 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03594994
- Sponsor's protocol ID
- 201805183
- Other IDs
- R01DK115502
- Status last verified
- Nov 2025
- First submitted
- 28 Jun 2018
- Last updated
- 11 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Effects of Sleep Extension in People With Obesity
- ClinicalTrials.gov ID
- NCT03594994
- Acronym / sponsor ID
- 201805183
- Conditions
- Insulin Resistance, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 29 Oct 2018 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 23 Jul 2018 (actual)
- Results
- Posted 11 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to determine the impact of extending sleep duration on glucose metabolism in people with obesity. Half of the participants will be instructed to increase their time-in-bed in order to achieve >7h sleep/night (sleep extension; n=15) while the other half will be be instructed to maintain their current sleep habits (n=15).
Detailed description
Restricting sleep is known to be detrimental to glucose metabolism in healthy adults. Obesity is a condition associated with both lower sleep duration and poor glucose tolerance. Therefore, increasing sleep duration is a potentially novel therapeutic strategy for improving glucose metabolism in this population. The investigators will assess this by determining insulin sensitivity during a hyperinsulinemic-euglycemic clamp before and after a sleep intervention in both the control and sleep extension groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Maintain their usual sleep patterns |
| Sleep Extension | Experimental | Behavioral: Sleep extensionExtend sleep duration to >7h/night; 15 participants |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Sleep <7h/night
- Body mass index 25-50 kg/m2
- Altered glucose metabolism (any of the following) Fasting glucose 100-125 mg/dL or, 2-h plasma glucose 140-199 mg/dL during an oral glucose tolerance test (OGTT) or, HbA1c 5.7-6.4% or, homeostatic model assessment of insulin resistance (HOMA-IR) ≥2.0
Key exclusion criteria (14 listed)
- Sleep disorders
- Perform shift work
- Excessive caffeine or alcohol consumption
- Significant organ dysfunction/disease (e.g. diabetes mellitus, kidney disease)
- Liver disease other than metabolic dysfunction associated steatotic liver disease (MASLD)
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 extensionExtend time-in-bed by one hour | Behavioural | Sleep Extension |
Primary outcome
Insulin Sensitivity
Time frame: Change from baseline testing after 4-6 weeks of intervention
Whole-body insulin sensitivity calculated as the insulin stimulated rate of glucose disposal per kilogram of fat-free body mass (µmol/kgFFM/min) during a hyperinsulinemic-euglycemic clamp.
17 secondary outcomes
Hepatic Insulin Sensitivity Index
Time frame: Change from baseline testing after 4-6 weeks of intervention
Adipose Tissue Insulin Sensitivity Index
Time frame: Change from baseline testing after 4-6 weeks of intervention
Homeostatic Model Assessment of Insulin Resistance
Time frame: Change from baseline testing after 4-6 weeks of intervention
24 Hour Glucose Area Under the Concentration Curve
Time frame: Change from baseline testing after 4-6 weeks of intervention
24 Hour Insulin Area Under the Concentration Curve
Time frame: Change from baseline testing after 4-6 weeks of intervention
24 Hour Non-esterified Fatty Acids Area Under the Concentration Curve
Time frame: Change from baseline testing after 4-6 weeks of intervention
Body Mass
Time frame: Change from baseline testing after 4-6 weeks of intervention
Fat-free Mass
Time frame: Change from baseline testing after 4-6 weeks of intervention
Body Fat
Time frame: Change from baseline testing after 4-6 weeks of intervention
Liver Fat
Time frame: Change from baseline testing after 4-6 weeks of intervention
Fasting Glucose
Time frame: Change from baseline testing after 4-6 weeks of intervention
Daily Time in Bed
Time frame: Change from baseline testing after 4-6 weeks of intervention
Daily Total Sleep Time
Time frame: Change from baseline testing after 4-6 weeks of intervention
Stage N1 Sleep Time
Time frame: Change from baseline testing after 4-6 weeks of intervention
Stage N2 Sleep Time
Time frame: Change from baseline testing after 4-6 weeks of intervention
Stage N3 Sleep Time
Time frame: Change from baseline testing after 4-6 weeks of intervention
Rapid Eye Movement (REM) Sleep Time
Time frame: Change from baseline testing after 4-6 weeks of intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 extension in people with Insulin Resistance and Obesity, run by Washington University School of Medicine 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 3 inclusion and 14 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 11 Dec 2025. 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?
Yes. Results are posted in the registry (first posted 11 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Insulin Sensitivity (time frame: Change from baseline testing after 4-6 weeks of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Dec 2025.