- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02075723
Effect of Sleep Restriction on Metabolic Disturbances Caused by Overfeeding
Study Overview
Status
Conditions
Detailed Description
General hypothesis :
In overfeeding condition, the stress response generated by partial sleep restriction of six days will induce an accumulation of fat in the liver and a decreased insulin sensitivity of adipose tissue , liver and muscle, more pronounced that in overfeeding condition only, provoked by a deregulation of the nocturnal lipolysis .
Specific goals :
Purpose 1 : To measure the accumulation of fat in the liver (measured by nuclear magnetic resonance ) and the tissue insulin sensitivity ( measured by a test meal ) in response to a sleep restriction in overfeeding condition .
Hypothesis 1: In overfeeding condition (130 % of energy requirements ) , hepatic lipid accumulation will be higher after 6 days of sleep restriction (4 hours per night) compared to a control condition (8 hours of sleep per night ) . Decreased sensitivity to insulin in the liver, adipose tissue and the associated muscle will be associated at this ectopic fat accumulation.
Purpose 2 : To determine the alteration of lipolysis in response to sleep restriction in overfeeding condition.
Hypothesis 2: In overfeeding condition, sleep restriction will increase the concentrations of circulating fatty acids and glycerol in relation to condition of normal sleep.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Vaud
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Lausanne, Vaud, Switzerland, 1011
- Recruiting
- Center for Investigation and Reseaarch on Sleep and Physiology Department, University Hospital
-
Contact:
- Virgile Lecoultre, PhD
- Phone Number: 0041 21 692 55 70
- Email: virgile.lecoultre@unil.ch
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Good general health
- BMI 18.5-25 kg/m2
- Blood pressure at rest less than 140/ 90 mmHg .
- Physical activity level: sedentary or light (< 3 hours of sport per week )
- Lack of sleep pathology ( including sleep apnea and insomnia )
- Regular sleep-wake cycles
- Average duration of sleep over 7h
- Circadian Typology by Horne & Ostberg questionnaire ≥ 30 and ≤ 70
- Score questionnaire Pittsburgh Sleep Quality Index ≤ 5
- Screening polysomnography showing sleep efficiency ≥ 85 % and apnea- hypopnea index and periodic leg movements < 15 / h .
Exclusion Criteria:
- Current smoking
- Family history of diabetes
- History of sleep disorders
- Circadian Typology by Horne & Ostberg [ 16-30 ] or [ 70-86 ]
- Score questionnaire Pittsburgh Sleep Quality Inde x> 5
- Polysomnography indicating a sleep efficiency <85% and apnea-hypopnea index and periodic leg movements > 15 / h.
- Consumption of more than 3 coffees a day
- Drinking alcool (more than 10g /d)
- Use of Drugs
- Medication
- Night work by shifts
- Average duration of sleep less than 7 hours per night
- Occupational Risks in sleep restriction conditions: e.g. professional drivers
- Special Diet ( vegetarianism, veganism , etc. )
- Change in weight of more than 3 kg in the last 3 months
- Consumption of more than 3 dl sugar-sweetened beverages per day ( sodas, energy drinks , fruit juice , flavored milk sugar )
- Contraindication for magnetic resonance imaging ( pacemaker , previous eye surgery, the presence of metal implant or foreign body, Claustrophobia, etc. )
- For women: pregnancy (current or desired)
- Hemoglobin level < 13.5g/dl for men and < 12.5g/dl for women
- Ferritin level < 50ug / l
- Blood donation in the last 8 weeks
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Overfeeding + sleep restriction
overfeeding condition (130 % of energy requirements ) + 6 days of sleep restriction (4 hours per night)
|
Overfeeding (130 % of energy requirements )
Sleep restriction (4 hours per night)
|
|
Experimental: Overfeeding + normal sleep duration
overfeeding condition (130 % of energy requirements ) + 6 days of normal sleep duration (8 hours per night)
|
Overfeeding (130 % of energy requirements )
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Accumulation of fat in the liver (measured by nuclear magnetic resonance ) and the tissue insulin sensitivity ( measured by a test meal ) in response to a sleep restriction in overfeeding condition .
Time Frame: After 6 days of sleep restriction (4 h/day) vs. normal sleep (8 h/day)
|
After 6 days of sleep restriction (4 h/day) vs. normal sleep (8 h/day)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Blood concentrations of circulating fatty acids and glycerol
Time Frame: After 6 days of sleep restriction (4 h/day) vs. normal sleep (8 h/day)
|
After 6 days of sleep restriction (4 h/day) vs. normal sleep (8 h/day)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: José Haba-Rubio, MD, Center for Investigation and Research on Sleep, University Hospital, Lausanne, Switzerland
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SleepDep 02/14
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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