Clinical trial NCT04214184: Biomarkers of Increased Free Living Sleep Time
Official title: Biomarkers and Altered Metabolic Pathways During Sleep Loss
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Deprivation
Insufficient Sleep Syndrome
Sleep Wake Disorders
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: University of Colorado, Boulder
First posted: 2020-01-02
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants with habitual insufficient sleep schedules will complete a 4-week increased sleep duration intervention targeting the recommended 7 hours of sleep per night.
Primary purpose: BASIC_SCIENCE

Brief summary: This protocol will increase sleep duration in participants who maintain less than 6 hours sleep per night, to target the recommended 7 hours of sleep per night. The focus of this study is determine how increasing nightly sleep duration in these individuals who maintain less than 6 hours sleep per night changes their plasma metabolome and insulin sensitivity. The primary outcome will examine changes in branched-chain amino acids and the secondary outcome will examine changes in insulin sensitivity. The investigators will also determine if changes in plasma metabolites can be used as a biomarker to discriminate between adequate versus insufficient sleep.

Detailed description: Impaired sleep affects millions of people each year representing an important public health issue. This project will utilize metabolomics approaches to identify potential mechanisms underlying increased cardiometabolic risk associated with insufficient sleep and to identify potential biomarkers in the blood that respond to insufficient sleep. Investigators will conduct a controlled in-laboratory insufficient protocol where participants will sleep in the lab for one night with sleep timing based on their habitual insufficient sleep schedule. In the morning, plasma will be collected for metabolomics analyses and participants will complete an oral glucose tolerance test for insulin sensitivity analyses. Participants will then complete a 4 -week increased sleep duration intervention targeting the recommended 7 hours of sleep per night. Following this intervention participants will again sleep in the lab for one night on their new sleep schedule. In the morning, plasma will be collected for metabolomics analyses and participants will complete an oral glucose tolerance test for insulin sensitivity analyses. Investigators anticipate these findings will be the first step in developing biomarkers of impaired sleep under free-living sleep conditions, and to determine how such biomarkers relate to insulin sensitivity changes associated with sleep loss.

Eligibility criteria: Inclusion Criteria:

1. 18-35 years old; men and women

   a. Equal numbers of women and men will be included.
2. Body Mass Index (BMI) of \> 18.5 and \<24.9.
3. Inactive to habitual moderate physical activity level (\<5 days of exercise per week).
4. Sleep/wake history: habitual sleep duration less than 6 hours per night.
5. Altitude history: Potential participants must have lived at Denver altitude or higher for at least 3 months.

Exclusion Criteria:

1. Any clinically significant unstable medical or surgical condition within the last year (treated or untreated).
2. Any clinically significant psychiatric condition, as defined by DSM-IV-TR. I
3. Any clinically significant sleep disorder.
4. Use of prescription medications/supplements within one month or need of these medications at any time during the study.
5. Symptoms of active illness (e.g., fever).
6. Uncorrected visual impairment
7. History of shift work in prior year or travel more than one time zone in three weeks prior to study.
8. Participants must be entirely drug-free of illicit drugs, medications, nicotine and herbal products for one month prior to study.
9. Blood donation in the 30 days prior to inpatient study.
10. Ovulating women will be selected on the basis of a history of regular menstrual cycle ranging in length from 25-32 days with a maximum of three days variation month-to-month. They will have no history of prior gynecological pathology, be at least 1 year post-partum, not breast-feeding and not pregnant (HCG pregnancy test at screening and upon admission to the inpatient protocol).

Primary outcomes:
measure: Metabolomics-branched chain amino acids change from baseline
timeFrame: Morning fasted blood will be collected for analyses at baseline and after the four week increased sleep duration intervention.
measure: Insulin Sensitivity change from baseline
timeFrame: Oral glucose tolerance testing will take about 3 hours to complete, and will be tested at baseline and after the four week increased sleep duration intervention.
Secondary outcomes:
measure: Untargeted Metabolomics change from baseline
timeFrame: Morning fasted blood will be collected for analyses at baseline and after the four week increased sleep duration intervention.
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Sleep Wake Center--University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Christopher Depner
role: PRINCIPAL_INVESTIGATOR
References: