NCT03594994

Metabolic Effects of Sleep Extension in People With Obesity

Completed NA Results posted Last updated 11 December 2025

What this trial tests

NA trial testing Sleep extension in Insulin Resistance in 31 participants. Completed in 30 July 2024.

Timeline

29 October 2018

Primary endpoint
15 July 2024

30 July 2024

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	31
Start date	29 October 2018
Primary completion	15 July 2024
Estimated completion	30 July 2024
Sites	1 location across United States

Drugs / interventions tested

• Sleep extension

Conditions studied

• Insulin Resistance — all drugs for Insulin Resistance →
• Obesity — all drugs for Obesity →

Sponsor

Washington University School of Medicine

Who can join

Adults 21 to 65, female only, with Insulin Resistance or Obesity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Insulin Sensitivity Primary · 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.

Group	Value	95% CI
Control	-3.8	-8.6 – 0.9
Sleep Extension	0.9	-5.0 – 6.8

Hepatic Insulin Sensitivity Index Secondary · 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.

Group	Value	95% CI
Control	0.4	-0.3 – 1.0
Sleep Extension	-0.3	-1.1 – 0.5

Adipose Tissue Insulin Sensitivity Index Secondary · 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.

Group	Value	95% CI
Control	2.4	-2.4 – 7.2
Sleep Extension	-2.0	-5.6 – 1.7

Homeostatic Model Assessment of Insulin Resistance Secondary · 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.

Group	Value	95% CI
Control	0.2	-0.6 – 0.9
Sleep Extension	0.3	-0.7 – 1.2

24 Hour Glucose Area Under the Concentration Curve Secondary · Change from baseline testing after 4-6 weeks of intervention

Plasma metabolite concentrations will be evaluated over a 24 hour period

Group	Value	95% CI
Control	45	0 – 90
Sleep Extension	41	-23 – 105

24 Hour Insulin Area Under the Concentration Curve Secondary · Change from baseline testing after 4-6 weeks of intervention

Plasma insulin concentrations evaluated over a 24 hour period

Group	Value	95% CI
Control	1	-196 – 197
Sleep Extension	-44	-197 – 109

24 Hour Non-esterified Fatty Acids Area Under the Concentration Curve Secondary · Change from baseline testing after 4-6 weeks of intervention

Plasma metabolite concentrations will be evaluated over a 24 hour period

Group	Value	95% CI
Control	1.0	0.1 – 2.0
Sleep Extension	-0.3	-1.3 – 0.7

Body Mass Secondary · Change from baseline testing after 4-6 weeks of intervention

Measured using a body weight scale

Group	Value	95% CI
Control	-1.1	-2.5 – 0.3
Sleep Extension	-0.3	-1.1 – 0.5

Fat-free Mass Secondary · Change from baseline testing after 4-6 weeks of intervention

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

Group	Value	95% CI
Control	-0.2	-1.1 – 0.7
Sleep Extension	-0.5	-1.6 – 0.7

Body Fat Secondary · Change from baseline testing after 4-6 weeks of intervention

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

Group	Value	95% CI
Control	0.5	-0.1 – 1.2
Sleep Extension	0.4	-0.2 – 1.0

Liver Fat Secondary · 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)

Group	Value	95% CI
Control	-0.63	-2.01 – 0.76
Sleep Extension	0.6	-0.04 – 1.26

Fasting Glucose Secondary · Change from baseline testing after 4-6 weeks of intervention

Plasma glucose measured after an overnight fast

Group	Value	95% CI
Control	3.6	0.6 – 6.7
Sleep Extension	0.8	-2.2 – 3.8

Adverse events — posted to ClinicalTrials.gov

Time frame: Before, during and after the 4-6 week intervention. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Control

Serious: 0/16 (0%)

Deaths: 0/16

Sleep Extension

Serious: 0/15 (0%)

Deaths: 0/15

Other adverse events (1 terms — click to expand)

Reaction	System	Control	Sleep Extension
Unrelated medical issue	Musculoskeletal and connective tissue disorders	—	—

Data from ClinicalTrials.gov NCT03594994 adverse events section.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Sleep Extension Improves Sleep Health but Not Insulin Sensitivity in People With Overweight or Obesity Who Maintain Habitual Short Sleep Schedules.
   Beals JW, Smith GI, Farabi SS, Patterson BW, et al · · 2026 · PMID 41564347 · DOI 10.2337/dc25-2083