NCT00915642

Brief Summary

The objectives of the present study are:

  1. 1.to evaluate if overnight weight loss is dependent on sleep structure assessed by polysomnography;
  2. 2.to compare weight loss rate during sleep and awake rest;
  3. 3.to compare night weight loss profile of normal and obese volunteers.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 8, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

August 3, 2009

Status Verified

July 1, 2009

Enrollment Period

2.3 years

First QC Date

June 4, 2009

Last Update Submit

July 31, 2009

Conditions

ObesityHealthy

Keywords

ObesityWeight loss rateSleepVigilMetabolismActigraphyNormal

Outcome Measures

Primary Outcomes (1)

  • Adaptation polysomnography (first night) followed by experimental polysomnography with continuous body weight register (second night)

    8 hours (first night), 8 hours (second night)

Secondary Outcomes (4)

  • Pletysmography

    1 hour (before second night), 1 hour (after second night), 1 hour (after daytime)

  • Actigraphy (nighttime, daytime)

    24 hours (second night, daytime following second night)

  • Skin temperature plot

    8 hours (second night), 8 hours (daytime following second night)

  • Daytime continuous weight register

    8 hours (daytime period following second night)

Study Arms (2)

Normal volunteers

Volunteers, body mass index 17 to 25

Obese volunteers

Volunteers body mass index higher than 30

Eligibility Criteria

Age21 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Normal and obese volunteers

You may qualify if:

  • normal and obese volunteers

You may not qualify if:

  • serious medical or neurological condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto do Sono / Associacao Fundo de Incentivo a Psicofarmacologia

São Paulo, São Paulo, 04020-060, Brazil

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Walter Moraes, MD PhD

    AFIP / UNIFESP

    PRINCIPAL INVESTIGATOR

  • Marco Tulio Mello, PhD

    AFIP / UNIFESP

    STUDY DIRECTOR

  • Sergio Tufik, MD, PhD

    AFIP/ UNIFESP

    STUDY CHAIR

Central Study Contacts

Walter Moraes, MD, PhD

CONTACT

55-11-5573-9238walter.moraes@afip.com.br

Marco Tulio Mello, PhD

CONTACT

55-5572-0177tmello@psicobio.epm.br

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 4, 2009

First Posted

June 8, 2009

Study Start

September 1, 2007

Primary Completion

January 1, 2010

Study Completion

May 1, 2010

Last Updated

August 3, 2009

Record last verified: 2009-07

Locations

BR(1)