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Metabolic Effects of Sleep Extension in People With Obesity

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ClinicalTrials.gov Identifier: NCT03594994
Recruitment Status : Suspended (Suspended due to Covid-19)
First Posted : July 23, 2018
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

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 to 8 hours (sleep extension) while the other half will be be instructed to maintain their current sleep habits.

Condition or disease Intervention/treatment Phase
Insulin Resistance Obesity Behavioral: Sleep extension Not Applicable

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 extension intervention in both the control and sleep extension groups.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Metabolic Effects of Sleep Extension in People With Obesity
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Arm Intervention/treatment
No Intervention: Control
Normal sleep habits < 6h
Experimental: Sleep Extension
Extend time-in-bed to 8 hours
Behavioral: Sleep extension
Extend time-in-bed to 8 hours




Primary Outcome Measures :
  1. Insulin Sensitivity [ Time Frame: Change from baseline testing after 4-6 weeks of intervention ]
    Whole-body insulin sensitivity during a hyperinsulinemic-euglycemic clamp


Secondary Outcome Measures :
  1. 24 hour metabolite concentrations [ Time Frame: Change from baseline testing after 4-6 weeks of intervention ]
    Plasma metabolite concentrations will be evaluated over a 24 hour period

  2. 24 hour hormone concentrations [ Time Frame: Change from baseline testing after 4-6 weeks of intervention ]
    Plasma hormone concentrations will be evaluated over a 24 hour period

  3. 24 hour cytokine concentrations [ Time Frame: Change from baseline testing after 4-6 weeks of intervention ]
    Plasma cytokine concentrations will be evaluated over a 24 hour period

  4. regulation of circadian rhythm [ Time Frame: Change from baseline testing after 4-6 weeks of intervention ]
    Expression of peripheral clock genes

  5. Body composition [ Time Frame: Change from baseline testing after 4-6 weeks of intervention ]
    Body composition will be assessed using dual-energy x-ray absorptiometry (DXA) and magnetic resonance scanning

  6. Sleep study [ Time Frame: Change from baseline testing after 4-6 weeks of intervention ]
    Sleep staging will be assessed during an inpatient sleep study



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Sleep <6h/night
  • Body mass index 30-45 kg/m2
  • Altered glucose metabolism (any of the following) Fasting glucose ≥100 mg/dL or, 2-h plasma glucose ≥140 mg/dL during an oral glucose tolerance test (OGTT) or, HbA1c ≥5.7% or, homeostatic model assessment of insulin resistance (HOMA-IR) ≥2.5

Exclusion Criteria:

  • Sleep disorders
  • Excessive caffeine or alcohol consumption
  • Significant organ dysfunction/disease (e.g. diabetes, kidney disease)
  • Prior bariatric surgery
  • Pregnancy
  • Tobacco or illicit drug use
  • Perform regular moderate or intense exercise

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03594994


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03594994    
Other Study ID Numbers: 201805183
First Posted: July 23, 2018    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Insulin Resistance
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases