Overnight Weight Loss and Sleep Structure

NCT ID: NCT00915642

Last Updated: 2009-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-09-30

Study Completion Date

2010-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Obesity Healthy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal volunteers

Volunteers, body mass index 17 to 25

No interventions assigned to this group

Obese volunteers

Volunteers body mass index higher than 30

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* normal and obese volunteers

Exclusion Criteria

* serious medical or neurological condition
Minimum Eligible Age

21 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

Associacao Fundo de Incentivo a Psicofarmcologia

OTHER

Sponsor Role lead

Responsible Party

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AFIP

Principal Investigators

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Walter Moraes, MD PhD

Role: PRINCIPAL_INVESTIGATOR

AFIP / UNIFESP

Marco Tulio Mello, PhD

Role: STUDY_DIRECTOR

AFIP / UNIFESP

Sergio Tufik, MD, PhD

Role: STUDY_CHAIR

AFIP/ UNIFESP

Locations

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Instituto do Sono / Associacao Fundo de Incentivo a Psicofarmacologia

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Walter Moraes, MD, PhD

Role: CONTACT

55-11-5573-9238

Marco Tulio Mello, PhD

Role: CONTACT

55-5572-0177

Facility Contacts

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Walter Moraes, MD, PhD

Role: primary

55-11-5573-9238

Marco Tulio Mello, PhD

Role: backup

55-11-5572-0177

Other Identifiers

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CEP1516/07

Identifier Type: -

Identifier Source: org_study_id

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