Obesity, AbdominalNCT03347604
Effect of Body Position on Spirometry in Abdominal Obesity.
An observational study of Obesity, Abdominal, run by Rush University Medical Center at 1 site in United States.
Trial summary
Objective: Study the effect of body position on spirometry in obese patients as defined by waist to hip ratio (WHR) of greater than 0.85 in women, and 0.9 in men Background: Spirometry is routinely ordered to work up dyspnea in obesity. The most common abnormality is a restrictive disease pattern. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Abdominal
- What is being tested?
- Supine spirometry, MIPs and MEPs
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2017to 30 Dec 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The target population is 30 medically stable obese patients with WHR > 0.85 in women, or > 0.9 in men, coming to outpatient clinic at Rush University Medical Center for complete pulmonary function testing.
Who may be able to join
- Individuals of both genders, age of 18 years or older
- Individuals with abdominal obesity with WHR > 0.85 in women, > 0.9 in men
- Ability of patients to transfer themselves into a cardiac chair
- Able to understand and comply with testing instructions
Who cannot join
- Patients who are less than 18 years old
- Patients who are unable to perform an acceptable and repeatable forced vital capacity
- Airflow limitation as evidenced by sitting FEV1/VC < lower limit of normal
- Patients who have a WHR < 0.85 in women, or < 0.9 in men
- Patients who become lightheaded during sitting spirometry
- Patients who cannot transfer themselves independently to a cardiac chair
Show all 10Show fewer
- History of lung disease (known obstructive or restrictive lung disease)
- Chest wall abnormalities or kyphoscoliosis
- Neuromuscular disease
- Active hemoptysis or recent angina
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Objective: Study the effect of body position on spirometry in obese patients as defined by waist to hip ratio (WHR) of greater than 0.85 in women, and 0.9 in men
Background: Spirometry is routinely ordered to work up dyspnea in obesity. The most common abnormality is a restrictive disease pattern. The underlying mechanisms of this pattern are not completely understood. One plausible explanation is diaphragmatic weakness or skeletal muscle weakness. The change in forced vital capacity (FVC) from sitting to supine is a very sensitive and specific test for detecting diaphragmatic weakness. The effect of body position on spirometry in obesity has not been extensively studied, and there are no studies that look at this when obesity is measured by waist to hip ratio. Effect of body position has been studied in normal patients, and it is expected the FVC can decrease as much as 10% when changing from sitting to supine. The investigators do not know what would be considered 'the normal' amount for FVC to decrease by in the obese population, and thus would like to test patients with increased WHR both in sitting and supine position. The investigators also want to do muscle strength test by measuring the maximal inspiratory and expiratory pressures (MIPs and MEPs).
Anticipated results: the investigators anticipate that our study population will replicate the restrictive disease pattern usually seen in obesity. The investigators also anticipate for the FVC to decrease when in the supine position compared to sitting. The amount by which it decreases will likely fall between 10 -25%. The investigators anticipate to not find any abnormalities in MIPs and MEPs in obesity.
Read the detailed description
The design for this study will be a cross-sectional study. This study will be conducted in the pulmonary function laboratory at Rush University Medical Center. A sample of subjects who meet the inclusion criteria will be selected from the adult population scheduled for CPFT lab appointments. The details of the study will be discussed by the respiratory therapist prior to the end of CPFT study. Information normally gathered in routine CPFTs includes oxygen saturation, height, and weight. Additional measures for subjects who accept the invitation to participate in this study will include measurements of BMI, waist circumference, and hip circumference. Inclusion criteria includes individuals of both genders, age of 18 years or older and individuals with abdominal obesity as defined by WHO as WHR greater than 0.85 in women, and 0.90 in men. Exclusion criteria include patients who cannot understand or comply with the spirometry test, known lung disease, obstructive ventilatory defect on CPFT, chest wall abnormalities/disorders, known neuromuscular disease, pregnant patients or prisoners.
The BMI (kg/m2) will be calculated as weight (in kilograms) divided by square of the height (in meters). Waist-hip ratio (WHR) will be measured in the standing position using a stretch-resistant tape. Waist circumference will be measured at a midpoint between the lowest rib and the middle of the iliac crest. The hip is defined as the maximal circumference around the gluteal muscles below the iliac crests.8,9 These measurements will be obtained by respiratory therapists who have been trained in obtaining WHR measurements using a standardized patient to assure measurement fidelity.
Spirometry measurements of FEV1 and FVC will be made in two testing positions for this study; the patients seated 90o upright (sitting position), and the patient fully supine position (0º horizontal decubitus position). FVC (forced vital capacity) is the volume of air in liters that can be forcibly and maximally exhaled after taking in the deepest breath. FEV1 is the volume of air that can be forcibly exhaled from the lungs in the first second of a forced expiratory maneuver and is reported in liters. Lung volumes will also be measured in the sitting position using either body plethysmography or nitrogen washout method as part of the routine CPFT testing. Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP), will also be measured in the sitting position and reported in centimeters of water (cm H2O). These reflect the maximum pressures generated by the patient on inhalation and exhalation, respectively and test respiratory muscle strength. All tests will be conducted in accordance with 2005 American Thoracic Society/European Respiratory Society guidelines13 using the Sensormedics Vmax pulmonary function system. The Vmax system is calibrated daily and reports all measurements at body temperature, pressure and water vapor. All tests will be performed by a team of respiratory therapists who have demonstrated annual competence following the recommendations of the American Thoracic Society/European Respiratory Society.14
Individuals who meet the study criteria and are able to successfully complete a CPFT will be recruited to participate in the study. After completing a consent form, the waist and hip measurements will be made. MIP and MEP measures will be made in the sitting position. Testing of spirometry will be repeated in the supine position. Sitting FEV1, FEV1 % predicted, FVC, FVC % predicted, FEV1/SVC, lower limit of normal for FEV1/FVC, supine FEV1, FEV1 % predicted, FVC, FVC % predicted, MIP, MEP, ERV, RV, FRC and TLC will be extracted from the pulmonary function test results and entered in REDCap for data tracking. Age, race, gender, and diagnosis code will be taken from the information routinely gathered for a pulmonary function test. The question related to smoking history will be asked directly of the subject. All data will be entered into REDCap.
Procedures done for research purposes and procedures done for routine clinical management:
A routine complete pulmonary function test (CPFT) as ordered by their referring provider includes measurements of slow vital capacity by spirometry, forced vital capacity by spirometry, lung diffusion by DLCO, and measurement of lung volume by body plethysmography. All of these measurements will be performed while the patient in sitting position. The additional testing for this study includes spirometry while the patient is in the supine position; and MIPs, and MEPs in the sitting position.
- Conditions
- Obesity, Abdominal
- Being tested
- Supine spirometry, MIPs and MEPs
- Medical subject headings
- Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supine spirometry, MIPs and MEPsDiagnostic test
We are going to test spirometry while in supine position , and also test respiratory muscles by measuring the maximum inspiratory and maximum expiratory efforts made by patients.
| Study group | Role | What they receive |
|---|---|---|
| Patients with abdominal obesity | Enrolling patients with abdominal obesity as defined by WHO to have waist to hop ratio of > 0.85 in women, or > 0.9 in men. Receives: Diagnostic Test: Supine spirometry, MIPs and MEPs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced expiratory volume in 1 second (FEV1, unit is Liters)
Investigators will measure FEV1 for patient in ight position.
Measured: first and only visit in study
Forced vital capacity (FVC , unit is Liters)
Investigators with measure FVC in upright position.
Measured: first and only visit in study
Forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC)
Ratio of FEV1/FVC in supine position.
Measured: first and only visit in study
Total lung capacity (TLC, unit is Liters).
Investigators will measure TLC in upright position.
Measured: first and only visit in study
Maximum inspiratory pressure (MIP, unit is cm of water).
Investigators will measure MIP in upright position.
Measured: first and only visit in study
Maximum expiratory pressure (MEP, unit is cm of water).
Investigators will measure MEP in upright position.
Measured: first and only visit in study
Forced vital capacity (FVC , unit is L)
Does supine position decrease forced vital capacity in abdominal obese ? Investigators will measure FVC in supine/lying down position.
Measured: first and only visit in study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start6 Oct 2017
- Primary completion30 Aug 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Obesity, AbdominalStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antranik Mangardich, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03347604
- Sponsor's protocol ID
- ORA: 17060206-IRB01
- Status last verified
- Jul 2019
- First submitted
- 24 Oct 2017
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kuczmarski RJ, Flegal KM, Campbell SM, Johnson CL. Increasing prevalence of overweight among US adults. The National Health and Nutrition Examination Surveys, 1960 to 1991. JAMA. 1994 Jul 20;272(3):205-11. doi: 10.1001/jama.272.3.205.
PubMed 8022039Obesity: preventing and managing the global epidemic. Report of a WHO consultation. World Health Organ Tech Rep Ser. 2000;894:i-xii, 1-253.
PubMed 11234459Guilbert JJ. The world health report 2002 - reducing risks, promoting healthy life. Educ Health (Abingdon). 2003 Jul;16(2):230. doi: 10.1080/1357628031000116808. No abstract available.
PubMed 14741909Wing RR, Matthews KA, Kuller LH, Meilahn EN, Plantinga P. Waist to hip ratio in middle-aged women. Associations with behavioral and psychosocial factors and with changes in cardiovascular risk factors. Arterioscler Thromb. 1991 Sep-Oct;11(5):1250-7. doi: 10.1161/01.atv.11.5.1250.
PubMed 1911710Saxena Y, Sidhwani G, Upmanyu R. Abdominal obesity and pulmonary functions in young Indian adults: a prospective study. Indian J Physiol Pharmacol. 2009 Oct-Dec;53(4):318-26.
PubMed 20509323Harik-Khan RI, Wise RA, Fleg JL. The effect of gender on the relationship between body fat distribution and lung function. J Clin Epidemiol. 2001 Apr;54(4):399-406. doi: 10.1016/s0895-4356(00)00318-8.
PubMed 11297889Al Ghobain M. The effect of obesity on spirometry tests among healthy non-smoking adults. BMC Pulm Med. 2012 Mar 21;12:10. doi: 10.1186/1471-2466-12-10.
PubMed 22436173Koenig SM. Pulmonary complications of obesity. Am J Med Sci. 2001 Apr;321(4):249-79. doi: 10.1097/00000441-200104000-00006.
PubMed 11307867TUCKER DH, SIEKER HO. The effect of change in body position on lung volumes and intrapulmonary gas mixing in patients with obesity, heart failure, and emphysema. Am Rev Respir Dis. 1960 Dec;82:787-91. doi: 10.1164/arrd.1960.82.6.787. No abstract available.
PubMed 13778537BLAIR E, HICKAM JB. The effect of change in body position on lung volume and intrapulmonary gas mixing in normal subjects. J Clin Invest. 1955 Mar;34(3):383-9. doi: 10.1172/JCI103086. No abstract available.
PubMed 14354008Shimokata H, Andres R, Coon PJ, Elahi D, Muller DC, Tobin JD. Studies in the distribution of body fat. II. Longitudinal effects of change in weight. Int J Obes. 1989;13(4):455-64.
PubMed 2676875Sievenpiper JL, Jenkins DJ, Josse RG, Leiter LA, Vuksan V. Simple skinfold-thickness measurements complement conventional anthropometric assessments in predicting glucose tolerance. Am J Clin Nutr. 2001 Mar;73(3):567-73. doi: 10.1093/ajcn/73.3.567.
PubMed 11237933Miller MR, Crapo R, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. General considerations for lung function testing. Eur Respir J. 2005 Jul;26(1):153-61. doi: 10.1183/09031936.05.00034505. No abstract available.
PubMed 15994402Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
PubMed 16055882Lung function testing: selection of reference values and interpretative strategies. American Thoracic Society. Am Rev Respir Dis. 1991 Nov;144(5):1202-18. doi: 10.1164/ajrccm/144.5.1202. No abstract available.
PubMed 1952453
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Body Position on Spirometry in Abdominal Obesity.
- ClinicalTrials.gov ID
- NCT03347604
- Acronym / sponsor ID
- ORA: 17060206-IRB01
- Conditions
- Obesity, Abdominal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 6 Oct 2017 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 20 Nov 2017 (actual)
- 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.
Objective: Study the effect of body position on spirometry in obese patients as defined by waist to hip ratio (WHR) of greater than 0.85 in women, and 0.9 in men
Background: Spirometry is routinely ordered to work up dyspnea in obesity. The most common abnormality is a restrictive disease pattern. The underlying mechanisms of this pattern are not completely understood. One plausible explanation is diaphragmatic weakness or skeletal muscle weakness. The change in forced vital capacity (FVC) from sitting to supine is a very sensitive and specific test for detecting diaphragmatic weakness. The effect of body position on spirometry in obesity has not been extensively studied, and there are no studies that look at this when obesity is measured by waist to hip ratio. Effect of body position has been studied in normal patients, and it is expected the FVC can decrease as much as 10% when changing from sitting to supine. The investigators do not know what would be considered 'the normal' amount for FVC to decrease by in the obese population, and thus would like to test patients with increased WHR both in sitting and supine position. The investigators also want to do muscle strength test by measuring the maximal inspiratory and expiratory pressures (MIPs and MEPs).
Anticipated results: the investigators anticipate that our study population will replicate the restrictive disease pattern usually seen in obesity. The investigators also anticipate for the FVC to decrease when in the supine position compared to sitting. The amount by which it decreases will likely fall between 10 -25%. The investigators anticipate to not find any abnormalities in MIPs and MEPs in obesity.
Detailed description
The design for this study will be a cross-sectional study. This study will be conducted in the pulmonary function laboratory at Rush University Medical Center. A sample of subjects who meet the inclusion criteria will be selected from the adult population scheduled for CPFT lab appointments. The details of the study will be discussed by the respiratory therapist prior to the end of CPFT study. Information normally gathered in routine CPFTs includes oxygen saturation, height, and weight. Additional measures for subjects who accept the invitation to participate in this study will include measurements of BMI, waist circumference, and hip circumference. Inclusion criteria includes individuals of both genders, age of 18 years or older and individuals with abdominal obesity as defined by WHO as WHR greater than 0.85 in women, and 0.90 in men. Exclusion criteria include patients who cannot understand or comply with the spirometry test, known lung disease, obstructive ventilatory defect on CPFT, chest wall abnormalities/disorders, known neuromuscular disease, pregnant patients or prisoners.
The BMI (kg/m2) will be calculated as weight (in kilograms) divided by square of the height (in meters). Waist-hip ratio (WHR) will be measured in the standing position using a stretch-resistant tape. Waist circumference will be measured at a midpoint between the lowest rib and the middle of the iliac crest. The hip is defined as the maximal circumference around the gluteal muscles below the iliac crests.8,9 These measurements will be obtained by respiratory therapists who have been trained in obtaining WHR measurements using a standardized patient to assure measurement fidelity.
Spirometry measurements of FEV1 and FVC will be made in two testing positions for this study; the patients seated 90o upright (sitting position), and the patient fully supine position (0º horizontal decubitus position). FVC (forced vital capacity) is the volume of air in liters that can be forcibly and maximally exhaled after taking in the deepest breath. FEV1 is the volume of air that can be forcibly exhaled from the lungs in the first second of a forced expiratory maneuver and is reported in liters. Lung volumes will also be measured in the sitting position using either body plethysmography or nitrogen washout method as part of the routine CPFT testing. Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP), will also be measured in the sitting position and reported in centimeters of water (cm H2O). These reflect the maximum pressures generated by the patient on inhalation and exhalation, respectively and test respiratory muscle strength. All tests will be conducted in accordance with 2005 American Thoracic Society/European Respiratory Society guidelines13 using the Sensormedics Vmax pulmonary function system. The Vmax system is calibrated daily and reports all measurements at body temperature, pressure and water vapor. All tests will be performed by a team of respiratory therapists who have demonstrated annual competence following the recommendations of the American Thoracic Society/European Respiratory Society.14
Individuals who meet the study criteria and are able to successfully complete a CPFT will be recruited to participate in the study. After completing a consent form, the waist and hip measurements will be made. MIP and MEP measures will be made in the sitting position. Testing of spirometry will be repeated in the supine position. Sitting FEV1, FEV1 % predicted, FVC, FVC % predicted, FEV1/SVC, lower limit of normal for FEV1/FVC, supine FEV1, FEV1 % predicted, FVC, FVC % predicted, MIP, MEP, ERV, RV, FRC and TLC will be extracted from the pulmonary function test results and entered in REDCap for data tracking. Age, race, gender, and diagnosis code will be taken from the information routinely gathered for a pulmonary function test. The question related to smoking history will be asked directly of the subject. All data will be entered into REDCap.
Procedures done for research purposes and procedures done for routine clinical management:
A routine complete pulmonary function test (CPFT) as ordered by their referring provider includes measurements of slow vital capacity by spirometry, forced vital capacity by spirometry, lung diffusion by DLCO, and measurement of lung volume by body plethysmography. All of these measurements will be performed while the patient in sitting position. The additional testing for this study includes spirometry while the patient is in the supine position; and MIPs, and MEPs in the sitting position.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with abdominal obesity | – | Diagnostic Test: Supine spirometry, MIPs and MEPsEnrolling patients with abdominal obesity as defined by WHO to have waist to hop ratio of > 0.85 in women, or > 0.9 in men. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population is 30 medically stable obese patients with WHR > 0.85 in women, or > 0.9 in men, coming to outpatient clinic at Rush University Medical Center for complete pulmonary function testing.
Key inclusion criteria (4 listed)
- Individuals of both genders, age of 18 years or older
- Individuals with abdominal obesity with WHR > 0.85 in women, > 0.9 in men
- Ability of patients to transfer themselves into a cardiac chair
- Able to understand and comply with testing instructions
Key exclusion criteria (10 listed)
- Patients who are less than 18 years old
- Patients who are unable to perform an acceptable and repeatable forced vital capacity
- Airflow limitation as evidenced by sitting FEV1/VC < lower limit of normal
- Patients who have a WHR < 0.85 in women, or < 0.9 in men
- Patients who become lightheaded during sitting spirometry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supine spirometry, MIPs and MEPsWe are going to test spirometry while in supine position , and also test respiratory muscles by measuring the maximum inspiratory and maximum expiratory efforts made by patients. | Diagnostic test | Patients with abdominal obesity |
Primary outcome
Forced expiratory volume in 1 second (FEV1, unit is Liters)
Time frame: first and only visit in study
Investigators will measure FEV1 for patient in ight position.
Forced vital capacity (FVC , unit is Liters)
Time frame: first and only visit in study
Investigators with measure FVC in upright position.
Forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC)
Time frame: first and only visit in study
Ratio of FEV1/FVC in supine position.
Total lung capacity (TLC, unit is Liters).
Time frame: first and only visit in study
Investigators will measure TLC in upright position.
Maximum inspiratory pressure (MIP, unit is cm of water).
Time frame: first and only visit in study
Investigators will measure MIP in upright position.
Maximum expiratory pressure (MEP, unit is cm of water).
Time frame: first and only visit in study
Investigators will measure MEP in upright position.
Forced vital capacity (FVC , unit is L)
Time frame: first and only visit in study
Does supine position decrease forced vital capacity in abdominal obese ? Investigators will measure FVC in supine/lying down position.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
- Background: PubMed 8022039Kuczmarski RJ, Flegal KM, Campbell SM, Johnson CL. Increasing prevalence of overweight among US adults. The National Health and Nutrition Examination Surveys, 1960 to 1991. JAMA. 1994 Jul 20;272(3):205-11. doi: 10.1001/jama.272.3.205.
- Background: PubMed 11234459Obesity: preventing and managing the global epidemic. Report of a WHO consultation. World Health Organ Tech Rep Ser. 2000;894:i-xii, 1-253.
- Background: PubMed 14741909Guilbert JJ. The world health report 2002 - reducing risks, promoting healthy life. Educ Health (Abingdon). 2003 Jul;16(2):230. doi: 10.1080/1357628031000116808. No abstract available.
- Background: PubMed 1911710Wing RR, Matthews KA, Kuller LH, Meilahn EN, Plantinga P. Waist to hip ratio in middle-aged women. Associations with behavioral and psychosocial factors and with changes in cardiovascular risk factors. Arterioscler Thromb. 1991 Sep-Oct;11(5):1250-7. doi: 10.1161/01.atv.11.5.1250.
- Background: PubMed 20509323Saxena Y, Sidhwani G, Upmanyu R. Abdominal obesity and pulmonary functions in young Indian adults: a prospective study. Indian J Physiol Pharmacol. 2009 Oct-Dec;53(4):318-26.
- Background: PubMed 11297889Harik-Khan RI, Wise RA, Fleg JL. The effect of gender on the relationship between body fat distribution and lung function. J Clin Epidemiol. 2001 Apr;54(4):399-406. doi: 10.1016/s0895-4356(00)00318-8.
- Background: PubMed 22436173Al Ghobain M. The effect of obesity on spirometry tests among healthy non-smoking adults. BMC Pulm Med. 2012 Mar 21;12:10. doi: 10.1186/1471-2466-12-10.
- Background: PubMed 11307867Koenig SM. Pulmonary complications of obesity. Am J Med Sci. 2001 Apr;321(4):249-79. doi: 10.1097/00000441-200104000-00006.
- Background: PubMed 13778537TUCKER DH, SIEKER HO. The effect of change in body position on lung volumes and intrapulmonary gas mixing in patients with obesity, heart failure, and emphysema. Am Rev Respir Dis. 1960 Dec;82:787-91. doi: 10.1164/arrd.1960.82.6.787. No abstract available.
- Background: PubMed 14354008BLAIR E, HICKAM JB. The effect of change in body position on lung volume and intrapulmonary gas mixing in normal subjects. J Clin Invest. 1955 Mar;34(3):383-9. doi: 10.1172/JCI103086. No abstract available.
- Background: PubMed 2676875Shimokata H, Andres R, Coon PJ, Elahi D, Muller DC, Tobin JD. Studies in the distribution of body fat. II. Longitudinal effects of change in weight. Int J Obes. 1989;13(4):455-64.
- Background: PubMed 11237933Sievenpiper JL, Jenkins DJ, Josse RG, Leiter LA, Vuksan V. Simple skinfold-thickness measurements complement conventional anthropometric assessments in predicting glucose tolerance. Am J Clin Nutr. 2001 Mar;73(3):567-73. doi: 10.1093/ajcn/73.3.567.
- Individual participant dataSharing planned: Undecided
Related trials for Obesity, Abdominal
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
Active, not recruiting
Influence of FreeO2 on Percentage of Time Within Oxygen Saturation Target Using Noninvasive Ventilation (NIV) and Continuous Positive Airway Pressure (CPAP) for Patients Admitted for AECOPD or Bariatric Surgery
COPD Exacerbation, Oxygen Toxicity
RecruitingObservational study
Asprosin and miRNA Expression in Young Women With Metabolic Syndrome
Metabolic Syndrome, Insulin Resistance
Not yet recruiting
Study on the Mechanism of Central Obesity Induced by Sleep Restriction and the Therapeutic Effect of n-3 Polyunsaturated Fatty Acid: a Randomized, Double-blind, Placebo-controlled Trial (COSPA Study)
Sleep Deprivation
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.
The record lists no contact. Use the official record to reach the sponsor.
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, Abdominal, run by Rush University Medical Center at 1 site in United States.
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 8 Jul 2019. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced expiratory volume in 1 second (FEV1, unit is Liters) (time frame: first and only visit in study). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03347604, which also lists 26 linked publications.
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 8 Jul 2019.