NCT00865293

Brief Summary

The purpose of this study is to investigate posture dependent small airway obstruction in subjects with obesity, and to study the capacity of FOT as a measurement tool for small airways obstruction.

Trial Health

50
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 19, 2009

Completed
Last Updated

July 14, 2009

Status Verified

July 1, 2009

First QC Date

March 18, 2009

Last Update Submit

July 13, 2009

Conditions

Obesity

Keywords

Obesityexpiratory flow limitationEFLposturesmall airways obstructionFOT

Outcome Measures

Primary Outcomes (1)

  • The difference in mean values of FEF25-75/FVC between subjects with obesity and controls in supine position

    6 months

Secondary Outcomes (1)

  • The capacity of FOT as a measurement tool for small airways obstruction. The effects of posture and obesity on lung volumes, diffusion capacity, air flow limitation. The effect of bronchodilation by salbutamol on posture dependent flow limitation.

    6 months

Study Arms (2)

Obesity

Subjects with obesity, defined as BMI \> 30, aged 25-60

Control

Subjects with a BMI 18,5-25, aged 25-60

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healty volunteers

You may qualify if:

  • Male/female, age 25-60
  • BMI (body mass index) 30-40 kg/m2
  • Non or ex smokers with \< 10 packyears
  • Male/female, age 25-60
  • BMI (body mass index) 18.5-25 kg/m2
  • Non or ex smokers with \<10 packyears

You may not qualify if:

  • Asthma
  • COPD (FEV1/FVC\<0.70)
  • Reversibility \>9% in FEV1 (400 microgram salbutamol)
  • Other significant neuromuscular, cardiac or lung disease
  • Asthma
  • COPD (FEV1/FVC\<0.70)
  • Other significant neuromuscular, cardiac or lung disease
  • Reversibility \>9% in FEV1 (400 microgram salbutamol)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • J. G. van den Aardweg

    Medical Center Alkmaar

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 18, 2009

First Posted

March 19, 2009

Study Start

July 1, 2008

Last Updated

July 14, 2009

Record last verified: 2009-07