Loughborough University
Loughborough, LE11 3TU, United Kingdom
NCT Number: NCT04467268
The study aims to examine the effects of a sleep extension intervention on the metabolic and cardio-vascular profile of obese people who present traditional diabetes risk factors, and who are habitually sleep deprived. Participants randomized to the intervention arm will complete a 6-week sleep extension intervention, whilst the control group will maintain their habitual sleep schedule. It is hypothesized that the sleep extension intervention will significantly increase total sleep time, and will be accompanied by significant metabolic-related changes.
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Notify Me25 year–55 year
Male
Interventional
Not applicable
Loughborough, LE11 3TU, United Kingdom
Recent epidemiological (survey) research, conducted in both in healthy populations and among those with existing chronic disease, shows that insufficient sleep can significantly contribute to ill health (including diabetes, heart disease and obesity). These findings have also been accompanied by credible explanatory mechanisms emphasising the role of sleep in regulating appetite, satiety, glucose and daytime stamina. Sleep extension, therefore, is a largely unexplored pathway for improving individual health, and reducing an existing risk of diabetes. If successful, increased sleep duration and quality could be adopted as an achievable public health intervention.
The study aims to recruit a total of 20 men, overweight, presenting traditional risks of developing diabetes, who are habitually short sleepers. Participants are then randomized, stratified by weight status, to a sleep extension group, or a control sleep monitoring group. Baseline measures include sleep actigraphy, continuous glucose monitoring, blood pressure, and a mixed-meal tolerance test; after the 6-week intervention, the same measures are repeated.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The sleep extension programme was designed around four alternative assumptions: 1) that among this group of habitual short sleepers, extending time in bed (TIB) would represent a significant behavioral change to established night-time and daytime routines; 2) that for practical purposes (accommodating personal, family and work schedules) extended time in bed is best anchored against typical rise-times; 3) that sleep onset may represent a particular challenge for those advancing habitual bed-times by over 1 hour each night; and 4) that in consenting to the trial, participants were motivated to make and sustain behavioral change.
Time frame: 24 hours
Time asleep obtained every night, as measured by actigraphy (minutes).
Time frame: 24 hours
Time between getting into and getting out of bed (minutes)
Time frame: 24 hours
Time to fall asleep (minutes)
Time frame: 24 hours
Time awake after the first sleep period (minutes)
Time frame: 3-hour mixed meal tolerance test blood plasma samples: prior to the test meal (0 minutes), and at 30, 60, 90, 120, 150, and 180 minutes
Total area under the glucose concentration curve
Time frame: 3-hour mixed meal tolerance test blood plasma samples: prior to the test meal (0 minutes), and at 30, 60, 90, 120, 150, and 180 minutes
Total area under the insulin concentration curve
Time frame: 3-hour mixed meal tolerance test blood plasma samples: prior to the test meal (0 minutes), and at 30, 60, 90, 120, 150, and 180 minutes
Total area under the PYY concentration curve
Time frame: 3-hour mixed meal tolerance test blood plasma samples: prior to the test meal (0 minutes), and at 30, 60, 90, 120, 150, and 180 minutes
Total area under the ghrelin concentration curve
Time frame: 8-hour fasting blood samples
Fasting leptin levels
Time frame: 24 hours
Physical activity recorded with actigraphs
Time frame: 14 days
Obtained from all CGMs 24-hour blood glucose concentrations across the monitoring period with
Time frame: 24 hours
Mean blood glucose values exceeding one standard deviation of the 24-hour arithmetic average across the monitoring period
Time frame: 10 minutes
Measurements of arterial blood pressure were taken, each after resting in a supine position for 10 minutes in a fasting state
Time frame: One month
Self-reported measure of sleep quality, score range 0-21,higher scores indicate worse sleep quality.
Time frame: One week
Self-reported assessment of experienced fatigue, scores range from 1 to 50, higher scores indicate worse fatigue.
Loughborough University
Other
Sleep Extension in Overweight Short Sleepers: A Randomised Controlled Trial:
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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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