Overnight Weight Loss and Sleep Structure

Healthy Clinical Trial

— weightsleep  

Official title:

Overnight Weight Loss, Sleep Structure and the Endocrine System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00915642
• Other study ID #: CEP1516/07
• Status: Recruiting
• Phase: N/A
• First received: June 4, 2009
• Last updated: July 31, 2009
• Start date: September 2007
• Est. completion date: May 2010

Study information

• Verified date: July 2009
• Source: Associacao Fundo de Incentivo a Psicofarmcologia
• Contact: Walter Moraes, MD, PhD
• Phone: 55-11-5573-9238
• Email: walter.moraes[@]afip.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 35 Years

Eligibility

Inclusion Criteria:

• normal and obese volunteers

Exclusion Criteria:

• serious medical or neurological condition

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Healthy
• Obesity
• Weight Loss

Locations

Country	Name	City	State
Brazil	Instituto do Sono / Associacao Fundo de Incentivo a Psicofarmacologia	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Associacao Fundo de Incentivo a Psicofarmcologia	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adaptation polysomnography (first night) followed by experimental polysomnography with continuous body weight register (second night)		8 hours (first night), 8 hours (second night)	No
Secondary	Pletysmography		1 hour (before second night), 1 hour (after second night), 1 hour (after daytime)	No
Secondary	Actigraphy (nighttime, daytime)		24 hours (second night, daytime following second night)	No
Secondary	Skin temperature plot		8 hours (second night), 8 hours (daytime following second night)	No
Secondary	Daytime continuous weight register		8 hours (daytime period following second night)	No