Clinical trial NCT03594994: Metabolic Effects of Sleep Extension in People With Obesity
Official title: Metabolic Effects of Sleep Extension in People With Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Obesity
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2018-07-23
Enrollment: 31
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 by one hour (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.

Eligibility criteria: 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)

Primary outcomes:
measure: Insulin Sensitivity
timeFrame: Change from baseline testing after 4-6 weeks of intervention
Secondary outcomes:
measure: 24 hour metabolite concentrations
timeFrame: Change from baseline testing after 4-6 weeks of intervention
measure: 24 hour hormone concentrations
timeFrame: Change from baseline testing after 4-6 weeks of intervention
measure: Body composition
timeFrame: Change from baseline testing after 4-6 weeks of intervention
measure: Sleep study
timeFrame: Change from baseline testing after 4-6 weeks of intervention
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
References: