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
  Purpose

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.

Condition
Obesity
Healthy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Overnight Weight Loss, Sleep Structure and the Endocrine System

Resource links provided by NLM:


Further study details as provided by Associacao Fundo de Incentivo a Psicofarmcologia:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: September 2007
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Normal volunteers
Volunteers, body mass index 17 to 25
Obese volunteers
Volunteers body mass index higher than 30

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   21 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Normal and obese volunteers

Criteria

Inclusion Criteria:

  • normal and obese volunteers

Exclusion Criteria:

  • serious medical or neurological condition
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00915642

Contacts
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

Locations
Brazil
Instituto do Sono / Associacao Fundo de Incentivo a Psicofarmacologia Recruiting
Sao Paulo, Brazil, 04020-060
Contact: Walter Moraes, MD, PhD    55-11-5573-9238    walter.moraes@afip.com.br   
Contact: Marco Tulio Mello, PhD    55-11-5572-0177    tmello@psicobio.epm.br   
Principal Investigator: Sergio Tufik, MD, PhD         
Sub-Investigator: Marco Tulio Mello, PhD         
Sponsors and Collaborators
Associacao Fundo de Incentivo a Psicofarmcologia
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Walter Moraes, MD PhD AFIP / UNIFESP
Study Director: Marco Tulio Mello, PhD AFIP / UNIFESP
Study Chair: Sergio Tufik, MD, PhD AFIP/ UNIFESP
  More Information

No publications provided

Responsible Party: Walter Andre dos Santos Moraes, AFIP
ClinicalTrials.gov Identifier: NCT00915642     History of Changes
Other Study ID Numbers: CEP1516/07
Study First Received: June 4, 2009
Last Updated: July 31, 2009
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Associacao Fundo de Incentivo a Psicofarmcologia:
Obesity
Weight loss rate
Sleep
Vigil
Metabolism
Actigraphy
Normal

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on July 24, 2014