Overnight Weight Loss and Sleep Structure (weightsleep)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00915642|
Recruitment Status : Unknown
Verified July 2009 by Associacao Fundo de Incentivo a Psicofarmcologia.
Recruitment status was: Recruiting
First Posted : June 8, 2009
Last Update Posted : August 3, 2009
The objectives of the present study are:
- to evaluate if overnight weight loss is dependent on sleep structure assessed by polysomnography;
- to compare weight loss rate during sleep and awake rest;
- to compare night weight loss profile of normal and obese volunteers.
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Overnight Weight Loss, Sleep Structure and the Endocrine System|
|Study Start Date :||September 2007|
|Estimated Primary Completion Date :||January 2010|
|Estimated Study Completion Date :||May 2010|
Volunteers, body mass index 17 to 25
Volunteers body mass index higher than 30
- 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) ]
- Pletysmography [ Time Frame: 1 hour (before second night), 1 hour (after second night), 1 hour (after daytime) ]
- Actigraphy (nighttime, daytime) [ Time Frame: 24 hours (second night, daytime following second night) ]
- Skin temperature plot [ Time Frame: 8 hours (second night), 8 hours (daytime following second night) ]
- Daytime continuous weight register [ Time Frame: 8 hours (daytime period following second night) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00915642
|Contact: Walter Moraes, MD, PhDemail@example.com|
|Contact: Marco Tulio Mello, PhDfirstname.lastname@example.org|
|Instituto do Sono / Associacao Fundo de Incentivo a Psicofarmacologia||Recruiting|
|Sao Paulo, Brazil, 04020-060|
|Contact: Walter Moraes, MD, PhD 55-11-5573-9238 email@example.com|
|Contact: Marco Tulio Mello, PhD 55-11-5572-0177 firstname.lastname@example.org|
|Principal Investigator: Sergio Tufik, MD, PhD|
|Sub-Investigator: Marco Tulio Mello, PhD|
|Principal Investigator:||Walter Moraes, MD PhD||AFIP / UNIFESP|
|Study Director:||Marco Tulio Mello, PhD||AFIP / UNIFESP|
|Study Chair:||Sergio Tufik, MD, PhD||AFIP/ UNIFESP|