Overnight Weight Loss and Sleep Structure (weightsleep)
Recruitment status was Recruiting
| Tracking Information | |||||||||||||
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| First Received Date ICMJE | June 4, 2009 | ||||||||||||
| Last Updated Date | July 31, 2009 | ||||||||||||
| Start Date ICMJE | September 2007 | ||||||||||||
| Estimated Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||||||
| Original Primary Outcome Measures ICMJE |
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 ] | ||||||||||||
| Change History | Complete list of historical versions of study NCT00915642 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Overnight Weight Loss and Sleep Structure | ||||||||||||
| Official Title ICMJE | Overnight Weight Loss, Sleep Structure and the Endocrine System | ||||||||||||
| Brief Summary | The objectives of the present study are:
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| 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. |
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| Study Type ICMJE | Observational | ||||||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||||||
| Biospecimen | Not Provided | ||||||||||||
| Sampling Method | Non-Probability Sample | ||||||||||||
| Study Population | Normal and obese volunteers |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||
| Estimated Enrollment ICMJE | 60 | ||||||||||||
| Estimated Completion Date | May 2010 | ||||||||||||
| Estimated Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||||||||||
| Ages | 21 Years to 35 Years | ||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Brazil | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT00915642 | ||||||||||||
| Other Study ID Numbers ICMJE | CEP1516/07 | ||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||
| Responsible Party | Walter Andre dos Santos Moraes, AFIP | ||||||||||||
| Study Sponsor ICMJE | Associacao Fundo de Incentivo a Psicofarmcologia | ||||||||||||
| Collaborators ICMJE | Fundação de Amparo à Pesquisa do Estado de São Paulo | ||||||||||||
| Investigators ICMJE |
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| Information Provided By | Associacao Fundo de Incentivo a Psicofarmcologia | ||||||||||||
| Verification Date | July 2009 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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