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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK115502 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Maintain their usual sleep patterns | |
| Sleep Extension | Experimental | Extend sleep duration to >7h/night; 15 participants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep extension | Behavioral | Extend time-in-bed by one hour |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline testing after 4-6 weeks of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline testing after 4-6 weeks of intervention |
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Inclusion Criteria:
Exclusion Criteria:
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)
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)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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158 people were assessed for eligibility
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Maintain their usual sleep patterns; 16 participants |
| FG001 | Sleep Extension | Extend sleep duration to >7h/night; 15 participants |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Maintain their usual sleep patterns |
| BG001 | Sleep Extension | Extend sleep duration to >7h/night |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | µmol/kgFFM/min | Change from baseline testing after 4-6 weeks of intervention |
|
Before, during and after the 4-6 week intervention
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Maintain their usual sleep patterns | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unrelated medical issue | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Broken foot during the a motorcycle accident during the habitual sleep intervention period |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph Beals | Washington University | 314-362-8199 | bealsjw@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 8, 2025 | Nov 5, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 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. |
| 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. | 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 | 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 | 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 | Change from baseline testing after 4-6 weeks of intervention |
| Body Mass | Measured using a body weight scale | Change from baseline testing after 4-6 weeks of intervention |
| Fat-free Mass | Body composition assessed using dual-energy x-ray absorptiometry (DXA) | Change from baseline testing after 4-6 weeks of intervention |
| Body Fat | Body composition assessed using dual-energy x-ray absorptiometry (DXA) | 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) | Change from baseline testing after 4-6 weeks of intervention |
| Fasting Glucose | Plasma glucose measured after an overnight fast | Change from baseline testing after 4-6 weeks of intervention |
| Daily Time in Bed | Assessed by using actigraphy over 7 days | Change from baseline testing after 4-6 weeks of intervention |
| Daily Total Sleep Time | Assessed by using actigraphy over 7 days | Change from baseline testing after 4-6 weeks of intervention |
| Stage N1 Sleep Time | Assessed by using inpatient polysomnography | Change from baseline testing after 4-6 weeks of intervention |
| Stage N2 Sleep Time | Assessed by using inpatient polysomnography | Change from baseline testing after 4-6 weeks of intervention |
| Stage N3 Sleep Time | Assessed by using inpatient polysomnography | Change from baseline testing after 4-6 weeks of intervention |
| Rapid Eye Movement (REM) Sleep Time | Assessed by using inpatient polysomnography | Change from baseline testing after 4-6 weeks of intervention |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Body mass index | Mean | Standard Deviation | kg/m2 |
|
| Fasting glucose | Mean | Standard Deviation | mg/dL |
|
| 120 min glucose | Measured during an oral glucose tolerance test, 120 minutes after ingesting a 75-g beverage | Mean | Standard Deviation | mg/dL |
|
| 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. | Mean | Standard Deviation | 22.5/(µU/mL * mmol/L) |
|
| Hemoglobin A1c | Mean | Standard Deviation | % |
|
| Total sleep time | Measured using wrist actigraphy | Mean | Standard Deviation | hours |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | 1000/[(µIU/mL) * (µmol/kg FFM/min)] | Change from baseline testing after 4-6 weeks of intervention |
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | 1000/[(µIU/mL) * (µmol/kg FFM/min)] | Change from baseline testing after 4-6 weeks of intervention |
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | 22.5/(µU/mL * mmol/L) | Change from baseline testing after 4-6 weeks of intervention |
|
|
|
| Secondary | 24 Hour Glucose Area Under the Concentration Curve | Plasma metabolite concentrations will be evaluated over a 24 hour period | Posted | Mean | 95% Confidence Interval | mg/dL x 24 h | Change from baseline testing after 4-6 weeks of intervention |
|
|
|
| Secondary | 24 Hour Insulin Area Under the Concentration Curve | Plasma insulin concentrations evaluated over a 24 hour period | Posted | Mean | 95% Confidence Interval | mU/L x 24 h | Change from baseline testing after 4-6 weeks of intervention |
|
|
|
| Secondary | 24 Hour Non-esterified Fatty Acids Area Under the Concentration Curve | Plasma metabolite concentrations will be evaluated over a 24 hour period | Posted | Mean | 95% Confidence Interval | mg/dL x 24 h | Change from baseline testing after 4-6 weeks of intervention |
|
|
|
| Secondary | Body Mass | Measured using a body weight scale | Posted | Mean | 95% Confidence Interval | kg | Change from baseline testing after 4-6 weeks of intervention |
|
|
|
| Secondary | Fat-free Mass | Body composition assessed using dual-energy x-ray absorptiometry (DXA) | Posted | Mean | 95% Confidence Interval | kg | Change from baseline testing after 4-6 weeks of intervention |
|
|
|
| Secondary | Body Fat | Body composition assessed using dual-energy x-ray absorptiometry (DXA) | Posted | Mean | 95% Confidence Interval | % of total body mass | Change from baseline testing after 4-6 weeks of intervention |
|
|
|
| Secondary | Liver Fat | Proton-density fat fraction of the whole liver assessed by using magnetic resonance imaging (MRI) | Posted | Mean | 95% Confidence Interval | % of whole liver | Change from baseline testing after 4-6 weeks of intervention |
|
|
|
| Secondary | Fasting Glucose | Plasma glucose measured after an overnight fast | Posted | Mean | 95% Confidence Interval | mg/dL | Change from baseline testing after 4-6 weeks of intervention |
|
|
|
| Secondary | Daily Time in Bed | Assessed by using actigraphy over 7 days | Posted | Mean | 95% Confidence Interval | hours | Change from baseline testing after 4-6 weeks of intervention |
|
|
|
| Secondary | Daily Total Sleep Time | Assessed by using actigraphy over 7 days | Posted | Mean | 95% Confidence Interval | hours | Change from baseline testing after 4-6 weeks of intervention |
|
|
|
| Secondary | Stage N1 Sleep Time | Assessed by using inpatient polysomnography | Posted | Mean | 95% Confidence Interval | minutes | Change from baseline testing after 4-6 weeks of intervention |
|
|
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| Secondary | Stage N2 Sleep Time | Assessed by using inpatient polysomnography | Posted | Mean | 95% Confidence Interval | minutes | Change from baseline testing after 4-6 weeks of intervention |
|
|
|
| Secondary | Stage N3 Sleep Time | Assessed by using inpatient polysomnography | Posted | Mean | 95% Confidence Interval | minutes | Change from baseline testing after 4-6 weeks of intervention |
|
|
|
| Secondary | Rapid Eye Movement (REM) Sleep Time | Assessed by using inpatient polysomnography | Posted | Mean | 95% Confidence Interval | minutes | Change from baseline testing after 4-6 weeks of intervention |
|
|
|
| 16 |
| 0 |
| 16 |
| 1 |
| 16 |
| EG001 | Sleep Extension | Extend sleep duration to >7h/night; 15 participants Sleep extension: Extend time-in-bed by one hour | 0 | 15 | 0 | 15 | 0 | 15 |
|
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| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |