Effect of Sleep Restriction on Metabolic Disturbances Caused by Overfeeding

May 26, 2015 updated by: José HABA-RUBIO, University of Lausanne Hospitals
The purpose of this study is to determine if sleep restriction provokes an increase in risk factors for metabolic diseases, such as elevation of ectopic fat and decreased sensitivity to insulin. We propose to evaluate the effect of sleep restriction in a model of metabolic challenge (overfeeding) caricaturing the conditions of modern societies everyday life .

Study Overview

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

Interventional

Enrollment (Anticipated)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Vaud
      • Lausanne, Vaud, Switzerland, 1011
        • Recruiting
        • Center for Investigation and Reseaarch on Sleep and Physiology Department, University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: José Haba-Rubio, MD, Center for Investigation and Research on Sleep, University Hospital, Lausanne, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

February 27, 2014

First Submitted That Met QC Criteria

February 27, 2014

First Posted (Estimate)

March 3, 2014

Study Record Updates

Last Update Posted (Estimate)

May 27, 2015

Last Update Submitted That Met QC Criteria

May 26, 2015

Last Verified

May 1, 2015

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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