Overnight Weight Loss and Sleep Structure (weightsleep)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Associacao Fundo de Incentivo a Psicofarmcologia.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
Associacao Fundo de Incentivo a Psicofarmcologia
ClinicalTrials.gov Identifier:
NCT00915642
First received: June 4, 2009
Last updated: July 31, 2009
Last verified: July 2009

June 4, 2009
July 31, 2009
September 2007
January 2010   (final data collection date for primary outcome measure)
Adaptation polysomnography (first night) followed by experimental polysomnography with continuous body weight register (second night) [ Time Frame: 8 hours (first night), 8 hours (second night) ] [ Designated as safety issue: No ]
Adaptation polysomnography (first night) followed by experimental polysomnography with continuous body weight register (second night) [ Time Frame: first night, second night ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00915642 on ClinicalTrials.gov Archive Site
  • Pletysmography [ Time Frame: 1 hour (before second night), 1 hour (after second night), 1 hour (after daytime) ] [ Designated as safety issue: No ]
  • Actigraphy (nighttime, daytime) [ Time Frame: 24 hours (second night, daytime following second night) ] [ Designated as safety issue: No ]
  • Skin temperature plot [ Time Frame: 8 hours (second night), 8 hours (daytime following second night) ] [ Designated as safety issue: No ]
  • Daytime continuous weight register [ Time Frame: 8 hours (daytime period following second night) ] [ Designated as safety issue: No ]
  • Pletysmography [ Time Frame: before second night, after second night, after daytime ] [ Designated as safety issue: No ]
  • Actigraphy (nighttime, daytime) [ Time Frame: second night, daytime following second night ] [ Designated as safety issue: No ]
  • Skin temperature plot [ Time Frame: second night, daytime following second night ] [ Designated as safety issue: No ]
  • Daytime continuous weight register [ Time Frame: 7-hour daytime period following second night ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Overnight Weight Loss and Sleep Structure
Overnight Weight Loss, Sleep Structure and the Endocrine System

The objectives of the present study are:

  1. to evaluate if overnight weight loss is dependent on sleep structure assessed by polysomnography;
  2. to compare weight loss rate during sleep and awake rest;
  3. to compare night weight loss profile of normal and obese volunteers.

Weight loss can be caused by loss of body mass due to metabolism and by water loss as insensible water loss, sweating, or excretion in feces and urine. Eighty-three percent of the total weight loss is due to insensible water loss from airways and skin. Water loss rate varies according to changes in activity and ambient temperature and humidity. Although weight loss during sleep is a well-known phenomenon, there are no studies relating it to sleep structure or any other functions during the distinct sleep stages, particularly SWS and REM sleep. There is evidence suggesting a homeostatic mechanism for weight control in animal models and humans. This mechanism is thought to be dependent on energy intake, energy expenditure, and environmental conditions. The literature suggests that sleep is important for weight homeostasis on a long term since sleep shortage is associated with overweight status, but overnight weight variation had not yet been studied. Considering these facts, we hypothesized that the overnight weight loss rate is not uniform throughout the sleep period. We also intend to compare weight loss rate during sleep and awake rest.

Intervention: Normal and obese volunteers will undergo whole night polysomnography with continuous body weight and temperature register after an adaptation night. After that, volunteers will remain awake resting in bed during the following day for continuous weight and temperature register.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Normal and obese volunteers

  • Obesity
  • Healthy
Not Provided
  • Normal volunteers
    Volunteers, body mass index 17 to 25
  • Obese volunteers
    Volunteers body mass index higher than 30
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
May 2010
January 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • normal and obese volunteers

Exclusion Criteria:

  • serious medical or neurological condition
Male
21 Years to 35 Years
Yes
Contact: Walter Moraes, MD, PhD 55-11-5573-9238 walter.moraes@afip.com.br
Contact: Marco Tulio Mello, PhD 55-5572-0177 tmello@psicobio.epm.br
Brazil
 
NCT00915642
CEP1516/07
Yes
Walter Andre dos Santos Moraes, AFIP
Associacao Fundo de Incentivo a Psicofarmcologia
Fundação de Amparo à Pesquisa do Estado de São Paulo
Principal Investigator: Walter Moraes, MD PhD AFIP / UNIFESP
Study Director: Marco Tulio Mello, PhD AFIP / UNIFESP
Study Chair: Sergio Tufik, MD, PhD AFIP/ UNIFESP
Associacao Fundo de Incentivo a Psicofarmcologia
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP