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Completed

NCT Number: NCT03594994

Metabolic Effects of Sleep Extension in People With Obesity

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).

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Key information

Conditions

Insulin Resistance Body Weight Glucose Metabolism Disorders Hyperinsulinism Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • moderate to severe sleep apnea (apnea-hypopnea index ≥15 events/hour)
  • had ≥15 periodic limb movements per hour sleep [PLMS]
  • 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)

Treatment and study plan

Sleep Extension

Behavioral

Extend time-in-bed by one hour

Primary outcomes

  1. Insulin Sensitivity

    Time frame: 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 outcomes

  1. Hepatic Insulin Sensitivity Index

    Time frame: 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.

  2. Adipose Tissue Insulin Sensitivity Index

    Time frame: 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.

  3. Homeostatic Model Assessment of Insulin Resistance

    Time frame: 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.

  4. 24 Hour Glucose Area Under the Concentration Curve

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

    Plasma metabolite concentrations will be evaluated over a 24 hour period

  5. 24 Hour Insulin Area Under the Concentration Curve

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

    Plasma insulin concentrations evaluated over a 24 hour period

  6. 24 Hour Non-esterified Fatty Acids Area Under the Concentration Curve

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

    Plasma metabolite concentrations will be evaluated over a 24 hour period

  7. Body Mass

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

    Measured using a body weight scale

  8. Fat-free Mass

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

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

  9. Body Fat

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

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

  10. Liver Fat

    Time frame: 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)

  11. Fasting Glucose

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

    Plasma glucose measured after an overnight fast

  12. Daily Time in Bed

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

    Assessed by using actigraphy over 7 days

  13. Daily Total Sleep Time

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

    Assessed by using actigraphy over 7 days

  14. Stage N1 Sleep Time

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

    Assessed by using inpatient polysomnography

  15. Stage N2 Sleep Time

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

    Assessed by using inpatient polysomnography

  16. Stage N3 Sleep Time

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

    Assessed by using inpatient polysomnography

  17. Rapid Eye Movement (REM) Sleep Time

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

    Assessed by using inpatient polysomnography

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Jul 23, 2018
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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