Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 11:58 PM
Study NCT ID:
NCT03594994
Status:
COMPLETED
Last Update Posted:
2025-12-11
First Post:
2018-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Metabolic Effects of Sleep Extension in People With Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bealsjw@wustl.edu', 'phone': '314-362-8199', 'title': 'Joseph Beals', 'organization': 'Washington University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Before, during and after the 4-6 week intervention', 'eventGroups': [{'id': 'EG000', 'title': 'Control', 'description': 'Maintain their usual sleep patterns', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 1, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sleep Extension', 'description': 'Extend sleep duration to \\>7h/night; 15 participants\n\nSleep extension: Extend time-in-bed by one hour', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Unrelated medical issue', 'notes': 'Broken foot during the a motorcycle accident during the habitual sleep intervention period', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Insulin Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Maintain their usual sleep patterns'}, {'id': 'OG001', 'title': 'Sleep Extension', 'description': 'Extend sleep duration to \\>7h/night'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.8', 'groupId': 'OG000', 'lowerLimit': '-8.6', 'upperLimit': '0.9'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '-5.0', 'upperLimit': '6.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline testing after 4-6 weeks of intervention', 'description': '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.', 'unitOfMeasure': 'µmol/kgFFM/min', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hepatic Insulin Sensitivity Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Maintain their usual sleep patterns'}, {'id': 'OG001', 'title': 'Sleep Extension', 'description': 'Extend sleep duration to \\>7h/night'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '-0.3', 'upperLimit': '1.0'}, {'value': '-0.3', 'groupId': 'OG001', 'lowerLimit': '-1.1', 'upperLimit': '0.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline testing after 4-6 weeks of intervention', 'description': '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.', 'unitOfMeasure': '1000/[(µIU/mL) * (µmol/kg FFM/min)]', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adipose Tissue Insulin Sensitivity Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Maintain their usual sleep patterns'}, {'id': 'OG001', 'title': 'Sleep Extension', 'description': 'Extend sleep duration to \\>7h/night'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000', 'lowerLimit': '-2.4', 'upperLimit': '7.2'}, {'value': '-2.0', 'groupId': 'OG001', 'lowerLimit': '-5.6', 'upperLimit': '1.7'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline testing after 4-6 weeks of intervention', 'description': 'Calculated as the reciprocal of the product of palmitate Ra/kgFFM and plasma insulin concentration during basal conditions. Higher values indicate greater insulin sensitivity.', 'unitOfMeasure': '1000/[(µIU/mL) * (µmol/kg FFM/min)]', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Homeostatic Model Assessment of Insulin Resistance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Maintain their usual sleep patterns'}, {'id': 'OG001', 'title': 'Sleep Extension', 'description': 'Extend sleep duration to \\>7h/night'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '-0.6', 'upperLimit': '0.9'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '-0.7', 'upperLimit': '1.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline testing after 4-6 weeks of intervention', 'description': '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.', 'unitOfMeasure': '22.5/(µU/mL * mmol/L)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '24 Hour Glucose Area Under the Concentration Curve', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Maintain their usual sleep patterns'}, {'id': 'OG001', 'title': 'Sleep Extension', 'description': 'Extend sleep duration to \\>7h/night'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '90'}, {'value': '41', 'groupId': 'OG001', 'lowerLimit': '-23', 'upperLimit': '105'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline testing after 4-6 weeks of intervention', 'description': 'Plasma metabolite concentrations will be evaluated over a 24 hour period', 'unitOfMeasure': 'mg/dL x 24 h', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '24 Hour Insulin Area Under the Concentration Curve', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Maintain their usual sleep patterns'}, {'id': 'OG001', 'title': 'Sleep Extension', 'description': 'Extend sleep duration to \\>7h/night'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '-196', 'upperLimit': '197'}, {'value': '-44', 'groupId': 'OG001', 'lowerLimit': '-197', 'upperLimit': '109'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline testing after 4-6 weeks of intervention', 'description': 'Plasma insulin concentrations evaluated over a 24 hour period', 'unitOfMeasure': 'mU/L x 24 h', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '24 Hour Non-esterified Fatty Acids Area Under the Concentration Curve', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Maintain their usual sleep patterns'}, {'id': 'OG001', 'title': 'Sleep Extension', 'description': 'Extend sleep duration to \\>7h/night'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '2.0'}, {'value': '-0.3', 'groupId': 'OG001', 'lowerLimit': '-1.3', 'upperLimit': '0.7'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline testing after 4-6 weeks of intervention', 'description': 'Plasma metabolite concentrations will be evaluated over a 24 hour period', 'unitOfMeasure': 'mg/dL x 24 h', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Body Mass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Maintain their usual sleep patterns'}, {'id': 'OG001', 'title': 'Sleep Extension', 'description': 'Extend sleep duration to \\>7h/night'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.1', 'groupId': 'OG000', 'lowerLimit': '-2.5', 'upperLimit': '0.3'}, {'value': '-0.3', 'groupId': 'OG001', 'lowerLimit': '-1.1', 'upperLimit': '0.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline testing after 4-6 weeks of intervention', 'description': 'Measured using a body weight scale', 'unitOfMeasure': 'kg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fat-free Mass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Maintain their usual sleep patterns'}, {'id': 'OG001', 'title': 'Sleep Extension', 'description': 'Extend sleep duration to \\>7h/night'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000', 'lowerLimit': '-1.1', 'upperLimit': '0.7'}, {'value': '-0.5', 'groupId': 'OG001', 'lowerLimit': '-1.6', 'upperLimit': '0.7'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline testing after 4-6 weeks of intervention', 'description': 'Body composition assessed using dual-energy x-ray absorptiometry (DXA)', 'unitOfMeasure': 'kg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Body Fat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Maintain their usual sleep patterns'}, {'id': 'OG001', 'title': 'Sleep Extension', 'description': 'Extend sleep duration to \\>7h/night'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '-0.1', 'upperLimit': '1.2'}, {'value': '0.4', 'groupId': 'OG001', 'lowerLimit': '-0.2', 'upperLimit': '1.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline testing after 4-6 weeks of intervention', 'description': 'Body composition assessed using dual-energy x-ray absorptiometry (DXA)', 'unitOfMeasure': '% of total body mass', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Liver Fat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Maintain their usual sleep patterns'}, {'id': 'OG001', 'title': 'Sleep Extension', 'description': 'Extend sleep duration to \\>7h/night'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.63', 'groupId': 'OG000', 'lowerLimit': '-2.01', 'upperLimit': '0.76'}, {'value': '0.6', 'groupId': 'OG001', 'lowerLimit': '-0.04', 'upperLimit': '1.26'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline testing after 4-6 weeks of intervention', 'description': 'Proton-density fat fraction of the whole liver assessed by using magnetic resonance imaging (MRI)', 'unitOfMeasure': '% of whole liver', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fasting Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Maintain their usual sleep patterns'}, {'id': 'OG001', 'title': 'Sleep Extension', 'description': 'Extend sleep duration to \\>7h/night'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '6.7'}, {'value': '0.8', 'groupId': 'OG001', 'lowerLimit': '-2.2', 'upperLimit': '3.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline testing after 4-6 weeks of intervention', 'description': 'Plasma glucose measured after an overnight fast', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Daily Time in Bed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Maintain their usual sleep patterns'}, {'id': 'OG001', 'title': 'Sleep Extension', 'description': 'Extend sleep duration to \\>7h/night'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '-0.2', 'upperLimit': '0.7'}, {'value': '1.3', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '1.7'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline testing after 4-6 weeks of intervention', 'description': 'Assessed by using actigraphy over 7 days', 'unitOfMeasure': 'hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Daily Total Sleep Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Maintain their usual sleep patterns'}, {'id': 'OG001', 'title': 'Sleep Extension', 'description': 'Extend sleep duration to \\>7h/night'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-0.2', 'upperLimit': '0.2'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '1.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline testing after 4-6 weeks of intervention', 'description': 'Assessed by using actigraphy over 7 days', 'unitOfMeasure': 'hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Stage N1 Sleep Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Maintain their usual sleep patterns'}, {'id': 'OG001', 'title': 'Sleep Extension', 'description': 'Extend sleep duration to \\>7h/night'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.3', 'groupId': 'OG000', 'lowerLimit': '-5.9', 'upperLimit': '3.2'}, {'value': '6.9', 'groupId': 'OG001', 'lowerLimit': '-1.6', 'upperLimit': '15.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline testing after 4-6 weeks of intervention', 'description': 'Assessed by using inpatient polysomnography', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Stage N2 Sleep Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Maintain their usual sleep patterns'}, {'id': 'OG001', 'title': 'Sleep Extension', 'description': 'Extend sleep duration to \\>7h/night'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.7', 'groupId': 'OG000', 'lowerLimit': '-52.3', 'upperLimit': '28.9'}, {'value': '23.9', 'groupId': 'OG001', 'lowerLimit': '11.8', 'upperLimit': '59.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline testing after 4-6 weeks of intervention', 'description': 'Assessed by using inpatient polysomnography', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Stage N3 Sleep Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Maintain their usual sleep patterns'}, {'id': 'OG001', 'title': 'Sleep Extension', 'description': 'Extend sleep duration to \\>7h/night'}], 'classes': [{'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000', 'lowerLimit': '-12.1', 'upperLimit': '21.0'}, {'value': '14.9', 'groupId': 'OG001', 'lowerLimit': '-2.6', 'upperLimit': '32.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline testing after 4-6 weeks of intervention', 'description': 'Assessed by using inpatient polysomnography', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rapid Eye Movement (REM) Sleep Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Maintain their usual sleep patterns'}, {'id': 'OG001', 'title': 'Sleep Extension', 'description': 'Extend sleep duration to \\>7h/night'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.6', 'groupId': 'OG000', 'lowerLimit': '-16.0', 'upperLimit': '12.8'}, {'value': '7.6', 'groupId': 'OG001', 'lowerLimit': '-21.9', 'upperLimit': '37.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline testing after 4-6 weeks of intervention', 'description': 'Assessed by using inpatient polysomnography', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control', 'description': 'Maintain their usual sleep patterns; 16 participants'}, {'id': 'FG001', 'title': 'Sleep Extension', 'description': 'Extend sleep duration to \\>7h/night; 15 participants'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '158 people were assessed for eligibility'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control', 'description': 'Maintain their usual sleep patterns'}, {'id': 'BG001', 'title': 'Sleep Extension', 'description': 'Extend sleep duration to \\>7h/night'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44', 'spread': '11', 'groupId': 'BG000'}, {'value': '39', 'spread': '13', 'groupId': 'BG001'}, {'value': '41.8', 'spread': '11.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White (Caucasian)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body mass index', 'classes': [{'categories': [{'measurements': [{'value': '34.8', 'spread': '5.6', 'groupId': 'BG000'}, {'value': '35.5', 'spread': '6.9', 'groupId': 'BG001'}, {'value': '35.2', 'spread': '6.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting glucose', 'classes': [{'categories': [{'measurements': [{'value': '94.9', 'spread': '5.0', 'groupId': 'BG000'}, {'value': '95.5', 'spread': '4.1', 'groupId': 'BG001'}, {'value': '95.2', 'spread': '4.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': '120 min glucose', 'classes': [{'categories': [{'measurements': [{'value': '133', 'spread': '29', 'groupId': 'BG000'}, {'value': '127', 'spread': '22', 'groupId': 'BG001'}, {'value': '130.1', 'spread': '25.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Measured during an oral glucose tolerance test, 120 minutes after ingesting a 75-g beverage', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Homeostatic model assessment of insulin resistance', 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'spread': '2.3', 'groupId': 'BG000'}, {'value': '4.6', 'spread': '2.3', 'groupId': 'BG001'}, {'value': '4.4', 'spread': '2.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '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.', 'unitOfMeasure': '22.5/(µU/mL * mmol/L)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hemoglobin A1c', 'classes': [{'categories': [{'measurements': [{'value': '5.4', 'spread': '0.3', 'groupId': 'BG000'}, {'value': '5.4', 'spread': '0.5', 'groupId': 'BG001'}, {'value': '5.4', 'spread': '0.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '%', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total sleep time', 'classes': [{'categories': [{'measurements': [{'value': '6.1', 'spread': '0.5', 'groupId': 'BG000'}, {'value': '5.8', 'spread': '0.5', 'groupId': 'BG001'}, {'value': '6.0', 'spread': '0.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Measured using wrist actigraphy', 'unitOfMeasure': 'hours', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-10-08', 'size': 450395, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-11-05T14:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-21', 'studyFirstSubmitDate': '2018-06-28', 'resultsFirstSubmitDate': '2025-10-14', 'studyFirstSubmitQcDate': '2018-07-11', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-21', 'studyFirstPostDateStruct': {'date': '2018-07-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulin Sensitivity', 'timeFrame': 'Change from baseline testing after 4-6 weeks of intervention', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Hepatic Insulin Sensitivity Index', 'timeFrame': 'Change from baseline testing after 4-6 weeks of intervention', 'description': '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.'}, {'measure': 'Adipose Tissue Insulin Sensitivity Index', 'timeFrame': 'Change from baseline testing after 4-6 weeks of intervention', 'description': 'Calculated as the reciprocal of the product of palmitate Ra/kgFFM and plasma insulin concentration during basal conditions. Higher values indicate greater insulin sensitivity.'}, {'measure': 'Homeostatic Model Assessment of Insulin Resistance', 'timeFrame': 'Change from baseline testing after 4-6 weeks of intervention', 'description': '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.'}, {'measure': '24 Hour Glucose Area Under the Concentration Curve', 'timeFrame': 'Change from baseline testing after 4-6 weeks of intervention', 'description': 'Plasma metabolite concentrations will be evaluated over a 24 hour period'}, {'measure': '24 Hour Insulin Area Under the Concentration Curve', 'timeFrame': 'Change from baseline testing after 4-6 weeks of intervention', 'description': 'Plasma insulin concentrations evaluated over a 24 hour period'}, {'measure': '24 Hour Non-esterified Fatty Acids Area Under the Concentration Curve', 'timeFrame': 'Change from baseline testing after 4-6 weeks of intervention', 'description': 'Plasma metabolite concentrations will be evaluated over a 24 hour period'}, {'measure': 'Body Mass', 'timeFrame': 'Change from baseline testing after 4-6 weeks of intervention', 'description': 'Measured using a body weight scale'}, {'measure': 'Fat-free Mass', 'timeFrame': 'Change from baseline testing after 4-6 weeks of intervention', 'description': 'Body composition assessed using dual-energy x-ray absorptiometry (DXA)'}, {'measure': 'Body Fat', 'timeFrame': 'Change from baseline testing after 4-6 weeks of intervention', 'description': 'Body composition assessed using dual-energy x-ray absorptiometry (DXA)'}, {'measure': 'Liver Fat', 'timeFrame': 'Change from baseline testing after 4-6 weeks of intervention', 'description': 'Proton-density fat fraction of the whole liver assessed by using magnetic resonance imaging (MRI)'}, {'measure': 'Fasting Glucose', 'timeFrame': 'Change from baseline testing after 4-6 weeks of intervention', 'description': 'Plasma glucose measured after an overnight fast'}, {'measure': 'Daily Time in Bed', 'timeFrame': 'Change from baseline testing after 4-6 weeks of intervention', 'description': 'Assessed by using actigraphy over 7 days'}, {'measure': 'Daily Total Sleep Time', 'timeFrame': 'Change from baseline testing after 4-6 weeks of intervention', 'description': 'Assessed by using actigraphy over 7 days'}, {'measure': 'Stage N1 Sleep Time', 'timeFrame': 'Change from baseline testing after 4-6 weeks of intervention', 'description': 'Assessed by using inpatient polysomnography'}, {'measure': 'Stage N2 Sleep Time', 'timeFrame': 'Change from baseline testing after 4-6 weeks of intervention', 'description': 'Assessed by using inpatient polysomnography'}, {'measure': 'Stage N3 Sleep Time', 'timeFrame': 'Change from baseline testing after 4-6 weeks of intervention', 'description': 'Assessed by using inpatient polysomnography'}, {'measure': 'Rapid Eye Movement (REM) Sleep Time', 'timeFrame': 'Change from baseline testing after 4-6 weeks of intervention', 'description': 'Assessed by using inpatient polysomnography'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Insulin Resistance', 'Obesity']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sleep \\<7h/night\n* Body mass index 25-50 kg/m2\n* 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\n\nExclusion Criteria:\n\n* Sleep disorders\n\n 1. moderate to severe sleep apnea (apnea-hypopnea index ≥15 events/hour)\n 2. had ≥15 periodic limb movements per hour sleep \\[PLMS\\]\n 3. narcolepsy or insomnia\n* Perform shift work\n* Excessive caffeine or alcohol consumption\n* Significant organ dysfunction/disease (e.g. diabetes mellitus, kidney disease)\n* Liver disease other than metabolic dysfunction associated steatotic liver disease (MASLD)\n* Prior bariatric surgery\n* Pregnancy or breastfeeding\n* Taking medications that can affect study outcomes (alter sleep duration or glucose metabolism)\n* Tobacco or illicit drug use\n* Perform intense exercise \\>70 min/wk or moderate exercise \\>150 min/week\n* Excessive alcohol consumption (\\>21 units of alcohol per week for men and \\>14 units of alcohol per week for women)'}, 'identificationModule': {'nctId': 'NCT03594994', 'briefTitle': 'Metabolic Effects of Sleep Extension in People With Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Metabolic Effects of Sleep Extension in People With Obesity', 'orgStudyIdInfo': {'id': '201805183'}, 'secondaryIdInfos': [{'id': 'R01DK115502', 'link': 'https://reporter.nih.gov/quickSearch/R01DK115502', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Maintain their usual sleep patterns'}, {'type': 'EXPERIMENTAL', 'label': 'Sleep Extension', 'description': 'Extend sleep duration to \\>7h/night; 15 participants', 'interventionNames': ['Behavioral: Sleep extension']}], 'interventions': [{'name': 'Sleep extension', 'type': 'BEHAVIORAL', 'description': 'Extend time-in-bed by one hour', 'armGroupLabels': ['Sleep Extension']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}