Metabolic Effects of Sleep Extension in People With Obesity

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03594994

Enrollment

Registered

2018-07-23

Start date

2018-10-29

Completion date

2024-07-30

Last updated

2025-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance, Obesity

Brief 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 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.

Interventions

BEHAVIORALSleep extension

Extend time-in-bed by one hour

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

21 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* 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

Exclusion criteria

* Sleep disorders 1. moderate to severe sleep apnea (apnea-hypopnea index ≥15 events/hour) 2. had ≥15 periodic limb movements per hour sleep \[PLMS\] 3. narcolepsy or insomnia * 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)

Design outcomes

Primary

Measure	Time frame	Description
Insulin Sensitivity	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.

Secondary

Measure	Time frame	Description
Adipose Tissue Insulin Sensitivity Index	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.
Homeostatic Model Assessment of Insulin Resistance	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.
24 Hour Glucose Area Under the Concentration Curve	Change from baseline testing after 4-6 weeks of intervention	Plasma metabolite concentrations will be evaluated over a 24 hour period
24 Hour Insulin Area Under the Concentration Curve	Change from baseline testing after 4-6 weeks of intervention	Plasma insulin concentrations evaluated over a 24 hour period
24 Hour Non-esterified Fatty Acids Area Under the Concentration Curve	Change from baseline testing after 4-6 weeks of intervention	Plasma metabolite concentrations will be evaluated over a 24 hour period
Daily Total Sleep Time	Change from baseline testing after 4-6 weeks of intervention	Assessed by using actigraphy over 7 days
Stage N1 Sleep Time	Change from baseline testing after 4-6 weeks of intervention	Assessed by using inpatient polysomnography
Stage N2 Sleep Time	Change from baseline testing after 4-6 weeks of intervention	Assessed by using inpatient polysomnography
Hepatic Insulin Sensitivity Index	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.
Body Mass	Change from baseline testing after 4-6 weeks of intervention	Measured using a body weight scale
Fat-free Mass	Change from baseline testing after 4-6 weeks of intervention	Body composition assessed using dual-energy x-ray absorptiometry (DXA)
Body Fat	Change from baseline testing after 4-6 weeks of intervention	Body composition assessed using dual-energy x-ray absorptiometry (DXA)
Liver Fat	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)
Rapid Eye Movement (REM) Sleep Time	Change from baseline testing after 4-6 weeks of intervention	Assessed by using inpatient polysomnography
Fasting Glucose	Change from baseline testing after 4-6 weeks of intervention	Plasma glucose measured after an overnight fast
Daily Time in Bed	Change from baseline testing after 4-6 weeks of intervention	Assessed by using actigraphy over 7 days
Stage N3 Sleep Time	Change from baseline testing after 4-6 weeks of intervention	Assessed by using inpatient polysomnography

Countries

United States

Participant flow

Recruitment details

158 people were assessed for eligibility

Participants by arm

Arm	Count
Control Maintain their usual sleep patterns	15
Sleep Extension Extend sleep duration to \>7h/night	14
Total	29

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	1	0
Overall Study	Withdrawal by Subject	0	1

Baseline characteristics

Characteristic	Total	Sleep Extension	Control
120 min glucose	130.1 mg/dL STANDARD_DEVIATION 25.4	127 mg/dL STANDARD_DEVIATION 22	133 mg/dL STANDARD_DEVIATION 29
Age, Continuous	41.8 years STANDARD_DEVIATION 11.8	39 years STANDARD_DEVIATION 13	44 years STANDARD_DEVIATION 11
Body mass index	35.2 kg/m2 STANDARD_DEVIATION 6.2	35.5 kg/m2 STANDARD_DEVIATION 6.9	34.8 kg/m2 STANDARD_DEVIATION 5.6
Fasting glucose	95.2 mg/dL STANDARD_DEVIATION 4.5	95.5 mg/dL STANDARD_DEVIATION 4.1	94.9 mg/dL STANDARD_DEVIATION 5
Hemoglobin A1c	5.4 % STANDARD_DEVIATION 0.4	5.4 % STANDARD_DEVIATION 0.5	5.4 % STANDARD_DEVIATION 0.3
Homeostatic model assessment of insulin resistance	4.4 22.5/(µU/mL * mmol/L) STANDARD_DEVIATION 2.3	4.6 22.5/(µU/mL * mmol/L) STANDARD_DEVIATION 2.3	4.3 22.5/(µU/mL * mmol/L) STANDARD_DEVIATION 2.3
Race/Ethnicity, Customized Asian	1 Participants	0 Participants	1 Participants
Race/Ethnicity, Customized Black	13 Participants	7 Participants	6 Participants
Race/Ethnicity, Customized White (Caucasian)	15 Participants	7 Participants	8 Participants
Sex: Female, Male Female	22 Participants	10 Participants	12 Participants
Sex: Female, Male Male	7 Participants	4 Participants	3 Participants
Total sleep time	6.0 hours STANDARD_DEVIATION 0.5	5.8 hours STANDARD_DEVIATION 0.5	6.1 hours STANDARD_DEVIATION 0.5

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 16	0 / 15
other Total, other adverse events	1 / 16	0 / 15
serious Total, serious adverse events	0 / 16	0 / 15

Outcome results

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.