Trial Outcomes & Findings for Metabolic Effects of Sleep Extension in People With Obesity (NCT NCT03594994)

NCT ID: NCT03594994

Last Updated: 2025-12-11

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 31 participants
• Primary outcome timeframe: Change from baseline testing after 4-6 weeks of intervention
• Results posted on: 2025-12-11

Participant Flow

158 people were assessed for eligibility

Participant milestones

Measure	Control Maintain their usual sleep patterns; 16 participants	Sleep Extension Extend sleep duration to \>7h/night; 15 participants
Overall Study STARTED	16	15
Overall Study COMPLETED	15	14
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Control Maintain their usual sleep patterns; 16 participants	Sleep Extension Extend sleep duration to \>7h/night; 15 participants
Overall Study Adverse Event	1	0
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Metabolic Effects of Sleep Extension in People With Obesity

Baseline characteristics by cohort

Measure	Control n=15 Participants Maintain their usual sleep patterns	Sleep Extension n=14 Participants Extend sleep duration to \>7h/night	Total n=29 Participants Total of all reporting groups
Age, Continuous	44 years STANDARD_DEVIATION 11 • n=237 Participants	39 years STANDARD_DEVIATION 13 • n=243 Participants	41.8 years STANDARD_DEVIATION 11.8 • n=480 Participants
Sex: Female, Male Female	12 Participants n=237 Participants	10 Participants n=243 Participants	22 Participants n=480 Participants
Sex: Female, Male Male	3 Participants n=237 Participants	4 Participants n=243 Participants	7 Participants n=480 Participants
Race/Ethnicity, Customized White (Caucasian)	8 Participants n=237 Participants	7 Participants n=243 Participants	15 Participants n=480 Participants
Race/Ethnicity, Customized Black	6 Participants n=237 Participants	7 Participants n=243 Participants	13 Participants n=480 Participants
Race/Ethnicity, Customized Asian	1 Participants n=237 Participants	0 Participants n=243 Participants	1 Participants n=480 Participants
Body mass index	34.8 kg/m2 STANDARD_DEVIATION 5.6 • n=237 Participants	35.5 kg/m2 STANDARD_DEVIATION 6.9 • n=243 Participants	35.2 kg/m2 STANDARD_DEVIATION 6.2 • n=480 Participants
Fasting glucose	94.9 mg/dL STANDARD_DEVIATION 5.0 • n=237 Participants	95.5 mg/dL STANDARD_DEVIATION 4.1 • n=243 Participants	95.2 mg/dL STANDARD_DEVIATION 4.5 • n=480 Participants
120 min glucose	133 mg/dL STANDARD_DEVIATION 29 • n=237 Participants	127 mg/dL STANDARD_DEVIATION 22 • n=243 Participants	130.1 mg/dL STANDARD_DEVIATION 25.4 • n=480 Participants
Homeostatic model assessment of insulin resistance	4.3 22.5/(µU/mL * mmol/L) STANDARD_DEVIATION 2.3 • n=237 Participants	4.6 22.5/(µU/mL * mmol/L) STANDARD_DEVIATION 2.3 • n=243 Participants	4.4 22.5/(µU/mL * mmol/L) STANDARD_DEVIATION 2.3 • n=480 Participants
Hemoglobin A1c	5.4 % STANDARD_DEVIATION 0.3 • n=237 Participants	5.4 % STANDARD_DEVIATION 0.5 • n=243 Participants	5.4 % STANDARD_DEVIATION 0.4 • n=480 Participants
Total sleep time	6.1 hours STANDARD_DEVIATION 0.5 • n=237 Participants	5.8 hours STANDARD_DEVIATION 0.5 • n=243 Participants	6.0 hours STANDARD_DEVIATION 0.5 • n=480 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Control n=15 Participants Maintain their usual sleep patterns	Sleep Extension n=14 Participants Extend sleep duration to \>7h/night
Insulin Sensitivity	-3.8 µmol/kgFFM/min Interval -8.6 to 0.9	0.9 µmol/kgFFM/min Interval -5.0 to 6.8

SECONDARY outcome

Timeframe: Change from baseline testing after 4-6 weeks of intervention

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.

Outcome measures

Measure	Control n=15 Participants Maintain their usual sleep patterns	Sleep Extension n=14 Participants Extend sleep duration to \>7h/night
Hepatic Insulin Sensitivity Index	0.4 1000/[(µIU/mL) * (µmol/kg FFM/min)] Interval -0.3 to 1.0	-0.3 1000/[(µIU/mL) * (µmol/kg FFM/min)] Interval -1.1 to 0.5

SECONDARY outcome

Timeframe: Change from baseline testing after 4-6 weeks of intervention

Calculated as the reciprocal of the product of palmitate Ra/kgFFM and plasma insulin concentration during basal conditions. Higher values indicate greater insulin sensitivity.

Outcome measures

Measure	Control n=13 Participants Maintain their usual sleep patterns	Sleep Extension n=14 Participants Extend sleep duration to \>7h/night
Adipose Tissue Insulin Sensitivity Index	2.4 1000/[(µIU/mL) * (µmol/kg FFM/min)] Interval -2.4 to 7.2	-2.0 1000/[(µIU/mL) * (µmol/kg FFM/min)] Interval -5.6 to 1.7

SECONDARY outcome

Timeframe: Change from baseline testing after 4-6 weeks of intervention

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.

Outcome measures

Measure	Control n=15 Participants Maintain their usual sleep patterns	Sleep Extension n=14 Participants Extend sleep duration to \>7h/night
Homeostatic Model Assessment of Insulin Resistance	0.2 22.5/(µU/mL * mmol/L) Interval -0.6 to 0.9	0.3 22.5/(µU/mL * mmol/L) Interval -0.7 to 1.2

SECONDARY outcome

Timeframe: Change from baseline testing after 4-6 weeks of intervention

Plasma metabolite concentrations will be evaluated over a 24 hour period

Outcome measures

Measure	Control n=13 Participants Maintain their usual sleep patterns	Sleep Extension n=12 Participants Extend sleep duration to \>7h/night
24 Hour Glucose Area Under the Concentration Curve	45 mg/dL x 24 h Interval 0.0 to 90.0	41 mg/dL x 24 h Interval -23.0 to 105.0

SECONDARY outcome

Timeframe: Change from baseline testing after 4-6 weeks of intervention

Plasma insulin concentrations evaluated over a 24 hour period

Outcome measures

Measure	Control n=13 Participants Maintain their usual sleep patterns	Sleep Extension n=12 Participants Extend sleep duration to \>7h/night
24 Hour Insulin Area Under the Concentration Curve	1 mU/L x 24 h Interval -196.0 to 197.0	-44 mU/L x 24 h Interval -197.0 to 109.0

SECONDARY outcome

Timeframe: Change from baseline testing after 4-6 weeks of intervention

Plasma metabolite concentrations will be evaluated over a 24 hour period

Outcome measures

Measure	Control n=13 Participants Maintain their usual sleep patterns	Sleep Extension n=12 Participants Extend sleep duration to \>7h/night
24 Hour Non-esterified Fatty Acids Area Under the Concentration Curve	1.0 mg/dL x 24 h Interval 0.1 to 2.0	-0.3 mg/dL x 24 h Interval -1.3 to 0.7

SECONDARY outcome

Timeframe: Change from baseline testing after 4-6 weeks of intervention

Measured using a body weight scale

Outcome measures

Measure	Control n=15 Participants Maintain their usual sleep patterns	Sleep Extension n=14 Participants Extend sleep duration to \>7h/night
Body Mass	-1.1 kg Interval -2.5 to 0.3	-0.3 kg Interval -1.1 to 0.5

SECONDARY outcome

Timeframe: Change from baseline testing after 4-6 weeks of intervention

Body composition assessed using dual-energy x-ray absorptiometry (DXA)

Outcome measures

Measure	Control n=15 Participants Maintain their usual sleep patterns	Sleep Extension n=14 Participants Extend sleep duration to \>7h/night
Fat-free Mass	-0.2 kg Interval -1.1 to 0.7	-0.5 kg Interval -1.6 to 0.7

SECONDARY outcome

Timeframe: Change from baseline testing after 4-6 weeks of intervention

Body composition assessed using dual-energy x-ray absorptiometry (DXA)

Outcome measures

Measure	Control n=15 Participants Maintain their usual sleep patterns	Sleep Extension n=14 Participants Extend sleep duration to \>7h/night
Body Fat	0.5 % of total body mass Interval -0.1 to 1.2	0.4 % of total body mass Interval -0.2 to 1.0

SECONDARY outcome

Timeframe: Change from baseline testing after 4-6 weeks of intervention

Proton-density fat fraction of the whole liver assessed by using magnetic resonance imaging (MRI)

Outcome measures

Measure	Control n=15 Participants Maintain their usual sleep patterns	Sleep Extension n=14 Participants Extend sleep duration to \>7h/night
Liver Fat	-0.63 % of whole liver Interval -2.01 to 0.76	0.6 % of whole liver Interval -0.04 to 1.26

SECONDARY outcome

Timeframe: Change from baseline testing after 4-6 weeks of intervention

Plasma glucose measured after an overnight fast

Outcome measures

Measure	Control n=15 Participants Maintain their usual sleep patterns	Sleep Extension n=14 Participants Extend sleep duration to \>7h/night
Fasting Glucose	3.6 mg/dL Interval 0.6 to 6.7	0.8 mg/dL Interval -2.2 to 3.8

SECONDARY outcome

Timeframe: Change from baseline testing after 4-6 weeks of intervention

Assessed by using actigraphy over 7 days

Outcome measures

Measure	Control n=15 Participants Maintain their usual sleep patterns	Sleep Extension n=14 Participants Extend sleep duration to \>7h/night
Daily Time in Bed	0.3 hours Interval -0.2 to 0.7	1.3 hours Interval 1.0 to 1.7

SECONDARY outcome

Timeframe: Change from baseline testing after 4-6 weeks of intervention

Assessed by using actigraphy over 7 days

Outcome measures

Measure	Control n=15 Participants Maintain their usual sleep patterns	Sleep Extension n=14 Participants Extend sleep duration to \>7h/night
Daily Total Sleep Time	0.0 hours Interval -0.2 to 0.2	1.1 hours Interval 0.8 to 1.4

SECONDARY outcome

Timeframe: Change from baseline testing after 4-6 weeks of intervention

Assessed by using inpatient polysomnography

Outcome measures

Measure	Control n=13 Participants Maintain their usual sleep patterns	Sleep Extension n=10 Participants Extend sleep duration to \>7h/night
Stage N1 Sleep Time	-1.3 minutes Interval -5.9 to 3.2	6.9 minutes Interval -1.6 to 15.3

SECONDARY outcome

Timeframe: Change from baseline testing after 4-6 weeks of intervention

Assessed by using inpatient polysomnography

Outcome measures

Measure	Control n=13 Participants Maintain their usual sleep patterns	Sleep Extension n=10 Participants Extend sleep duration to \>7h/night
Stage N2 Sleep Time	-11.7 minutes Interval -52.3 to 28.9	23.9 minutes Interval 11.8 to 59.6

SECONDARY outcome

Timeframe: Change from baseline testing after 4-6 weeks of intervention

Assessed by using inpatient polysomnography

Outcome measures

Measure	Control n=13 Participants Maintain their usual sleep patterns	Sleep Extension n=10 Participants Extend sleep duration to \>7h/night
Stage N3 Sleep Time	4.4 minutes Interval -12.1 to 21.0	14.9 minutes Interval -2.6 to 32.4

SECONDARY outcome

Timeframe: Change from baseline testing after 4-6 weeks of intervention

Assessed by using inpatient polysomnography

Outcome measures

Measure	Control n=13 Participants Maintain their usual sleep patterns	Sleep Extension n=10 Participants Extend sleep duration to \>7h/night
Rapid Eye Movement (REM) Sleep Time	-1.6 minutes Interval -16.0 to 12.8	7.6 minutes Interval -21.9 to 37.0

Adverse Events

Control

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Sleep Extension

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Control n=16 participants at risk Maintain their usual sleep patterns	Sleep Extension n=15 participants at risk Extend sleep duration to \>7h/night; 15 participants Sleep extension: Extend time-in-bed by one hour
Musculoskeletal and connective tissue disorders Unrelated medical issue	6.2% 1/16 • Number of events 1 • Before, during and after the 4-6 week intervention	0.00% 0/15 • Before, during and after the 4-6 week intervention

Additional Information

Joseph Beals

Washington University

Phone: 314-362-8199

Email: bealsjw@wustl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place