The Effects of Acute Total Sleep Deprivation Versus Normal Sleep on Metabolism

Sleep Clinical Trial

Official title:

The Role of Acute Total Sleep Deprivation in the Regulation of Metabolism, Neuroendocrine Responses, and Behavioral Measures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01800253
• Other study ID #: SleepMetaJCCB2013
• Status: Completed
• Phase: N/A
• First received: February 21, 2013
• Last updated: December 6, 2013
• Start date: March 2013
• Est. completion date: October 2013

Study information

• Verified date: November 2013
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The study proposes to investigate whether acute total deprivation affects metabolism as measured through blood and peripheral tissues. Its aim is also to investigate how acute total sleep deprivation affects neurodegenerative markers, as well as hormones, memory performance and aspects of appetite regulation.

Description:

It is predicted that acute total sleep deprivation will affect gene expression and DNA methylation. It is also predicted that sleep deprivation will up-regulate ghrelin, and affect other neuroendocrine markers and hormones in a negative manner. It is further predicted that sleep deprivation will decrease participants' memory performance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 28 Years

Eligibility

Inclusion Criteria:

• Male

• Age 18-28y

• Healthy (self-reported) and not on medication

• Non-smoking

• Normal sleep-wake rhythm (i.e. 7-8 h per night, self-reported via diaries)

Exclusion Criteria:

• Major illness

• Taking any serious medications

• Any sleep conditions (e.g. irregular bedtimes, sleep complaints)

• Any dietary issues with the food items provided

• Current or history of endocrine, neurological or psychiatric disorders

• Shift work in the preceding three months or for a long duration

• Time travel over a significant number of time zones in the preceding two months

• Too much weight gain or weight loss in the preceding three months

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Sleep
• Sleep Deprivation

Intervention

Behavioral:
• Inhibitory task
Participants perform a binary decision on each presented stimuli. Of the two possible outcomes, participants are instructed to make a motor response (go) for one type, and are to withhold a response (no-go) for the other type. Reaction time and accuracy are measured for each event

Procedure:
• Blood samples
Hormone levels, neuromolecular levels and gene expression profiles will be analyzed from repeated blood samples obtained before and after the nighttime intervention
• Tissue samples
Expression profiles will be analyzed from samples obtained from tissues involved in metabolism
• Oral glucose tolerance test
75 g of glucose will be dissolved in 300 ml of water and given to participants, followed by blood sampling at 0, 15, 30, 60, 90, 120 and 150 minutes following the ingestion of the glucose solution.

Behavioral:
• Portion Size Task
Participants are given a computer program that gives them the opportunity to choose the portions of a variety of food items that they would ideally like to consume

Locations

Country	Name	City	State
Sweden	Department of Neuroscience, Uppsala University	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gene expression and DNA methylation	This study has been designed to measure the changes in gene expression and DNA methylation in circulating blood, i.e. mainly of white blood cells with active transcription and DNA regulation, and how this relates to possible changes in peripheral tissues involved in metabolism.	Change from baseline (ie. around 1930 in the evening - before sleep intervention) to 12 hours later (around 0730 in the morning after the nighttime intervention), and to 15 hours later (around 1030 in the morning after the nighttime intervention)	No
Secondary	Circulating hormone and neuromolecular levels	Participants will have their circulating hormone levels and neuromolecular levels taken and analyzed, including ghrelin, to determine if sleep deprivation alters hormone and neuromolecular levels related primarily to obesity, cognition or weight gain	Change in circulating hormone levels from baseline (ie. around 1930 in the evening - before sleep intervention) to 12 hours later (around 0730 in the morning after the nighttime intervention)	No
Secondary	Appetitive evaluation	Participants will be evaluated on their appetitive ratings in the morning following either nighttime intervention (acute total sleep deprivation or normal 8-hour sleep).	Change in appetitive ratings after the sleep intervetion (from around 0700 in the morning after the nighttime intervention), repeated each hour	No
Secondary	Portion Size Task	Participants will be evaluated on their tendency to choose larger or smaller portions of a variety of meal items on a computer screen. This will be conducted both following partial sleep deprivation and normal sleep, and changes before and after glucose ingestion will be compared between these conditions	Change in selected portion size in the morning, at around 0830 hours in the morning following each nighttime intervention, and 2h30min later, i.e. 30 min after consuming an Oral glucose tolerance test, i.e. around 1100 hours	No
Secondary	Inhibitory task	Participants perform a binary decision on each presented stimuli. Of the two possible outcomes, participants are instructed to make a motor response (go) for one type, and are to withhold a response (no-go) for the other type. Reaction time and accuracy are measured for each event.	Change in cognitive inhibitory performance at around 0810 hours in the morning following the respective nighttime intervention.	No