ObesityweightsleepNCT00915642
Overnight Weight Loss and Sleep Structure
An observational study of Obesity and Healthy, run by Associacao Fundo de Incentivo a Psicofarmcologia at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 35 years, men onlyHealthy volunteers can take part
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2007to May 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Normal and obese volunteers
Who may be able to join
- normal and obese volunteers
Who cannot join
- serious medical or neurological condition
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Instituto do Sono / Associacao Fundo de Incentivo a Psicofarmacologia
São Paulo, São Paulo, 04020-060
Walter Moraes, MD, PhD, 55-11-5573-9238, walter.moraes@afip.com.br
Marco Tulio Mello, PhD, 55-11-5572-0177, tmello@psicobio.epm.br
About this study
Official title: Overnight Weight Loss, Sleep Structure and the Endocrine System
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.
Read the 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.
- Keywords
- Obesity, Weight loss rate, Sleep, Vigil, Metabolism, Actigraphy, Normal
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal volunteers | Volunteers, body mass index 17 to 25 | |
| Obese volunteers | Volunteers body mass index higher than 30 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adaptation polysomnography (first night) followed by experimental polysomnography with continuous body weight register (second night)
Measured: 8 hours (first night), 8 hours (second night)
Secondary outcomes (4)
Pletysmography
Measured: 1 hour (before second night), 1 hour (after second night), 1 hour (after daytime)
Actigraphy (nighttime, daytime)
Measured: 24 hours (second night, daytime following second night)
Skin temperature plot
Measured: 8 hours (second night), 8 hours (daytime following second night)
Daytime continuous weight register
Measured: 8 hours (daytime period following second night)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2009 (estimated)
- Study startSep 2007
- Primary completionJan 2010 (estimated)
- Study completionMay 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Associacao Fundo de Incentivo a Psicofarmcologia
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Investigators
- Walter Moraes, MD PhD, Principal investigator, AFIP / UNIFESPMarco Tulio Mello, PhD, Study director, AFIP / UNIFESPSergio Tufik, MD, PhD, Study chair, AFIP/ UNIFESP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00915642
- Sponsor's protocol ID
- CEP1516/07
- Acronym
- weightsleep
- Status last verified
- Jul 2009
- First submitted
- 4 Jun 2009
- Last updated
- 3 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overnight Weight Loss, Sleep Structure and the Endocrine System
- ClinicalTrials.gov ID
- NCT00915642
- Acronym / sponsor ID
- weightsleep / CEP1516/07
- Keywords
- Obesity, Weight loss rate, Sleep, Vigil, Metabolism, Actigraphy, Normal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Associacao Fundo de Incentivo a PsicofarmcologiaUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Sep 2007
- Primary completion
- Jan 2010 (estimated)
- Study completion
- May 2010 (estimated)
- First posted
- 8 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal volunteers | – | –Volunteers, body mass index 17 to 25 |
| Obese volunteers | – | –Volunteers body mass index higher than 30 |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Normal and obese volunteers
Key inclusion criteria (1 listed)
- normal and obese volunteers
Key exclusion criteria (1 listed)
- serious medical or neurological condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
4 secondary outcomes
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Walter Moraes, MD PhD principal investigator
AFIP / UNIFESP
Marco Tulio Mello, PhD study director
AFIP / UNIFESP
Sergio Tufik, MD, PhD study chair
AFIP/ UNIFESP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Healthy, run by Associacao Fundo de Incentivo a Psicofarmcologia at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Walter Moraes, MD, PhD (55-11-5573-9238, walter.moraes@afip.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2009.