ObesityNCT02644174
The Impact of Bariatric Surgery Induced Weight Loss on Lung Function in Adolescents
An observational study of Obesity, run by Rabin Medical Center at 1 site in Israel.
Trial summary
In this prospective study we will evaluate the changes in respiratory physiology occurring in morbidly obese adolescents following bariatric surgery at Schneider Children's Medical Center of Israel (SCMCI). Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Obesity
- What is being tested?
- Bariatric Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- May 2016to Jan 2023
- 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 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Adolescents with morbid obesity who will undergo bariatric surgery
Who may be able to join
- Adolescents with morbid obesity who will undergo bariatric surgery at the paediatric surgery ward of Schneider Children's Medical Center during 2016-2018
Who cannot join
- Adolescents with background diseases which might influence their ability to conduct pulmonary function tests (for example, patients with neurological disorders)
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Schneider Children's Medical Center of Israel
Petah Tikva, 49202
Patrick Stafler, MD, 972547243623, pstafler@hotmail.com
About this study
In this prospective study we will evaluate the changes in respiratory physiology occurring in morbidly obese adolescents following bariatric surgery at Schneider Children's Medical Center of Israel (SCMCI).
Read the detailed description
Morbid obesity leads to restrictive as well as obstructive ventilatory defects via mechanisms that include mechanical, as well as inflammatory factors. We hypothesise that multiple breath nitrogen washout will be more sensitive to changes in small airway function than conventional lung function testing.
We will invite adolescents with morbid obesity, scheduled to undergo bariatric surgery at SCMCI during 2016-2018, for pulmonary function testing, including spirometry, plethysmography, nitrogen multiple breath washout, lung transfer factor and 6 minute walk. These tests will be conducted prior to the operation as well as during follow-up appointments at 3, 6 and 12 months. We will also evaluate oxidative stress using highly sensitive C-reactive protein as surrogate marker.
- Conditions
- Obesity
- Being tested
- Bariatric Surgery
- Keywords
- Obesity, Lung function test, Bariatric surgery
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric SurgeryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Lung Clearance Index
Measured: 3 months post op
Secondary outcomes (1)
Change from Baseline High sensitivity C reactive protein
Measured: 3 months post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study startMay 2016
- Primary completionJan 2023 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Stafler, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02644174
- Sponsor's protocol ID
- 0126-16-RMC
- Status last verified
- Sep 2021
- First submitted
- 30 Dec 2015
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Peer reviewed journal
Publications
Li AM, Chan D, Wong E, Yin J, Nelson EA, Fok TF. The effects of obesity on pulmonary function. Arch Dis Child. 2003 Apr;88(4):361-3. doi: 10.1136/adc.88.4.361.
PubMed 12651773Lazarus R, Colditz G, Berkey CS, Speizer FE. Effects of body fat on ventilatory function in children and adolescents: cross-sectional findings from a random population sample of school children. Pediatr Pulmonol. 1997 Sep;24(3):187-94. doi: 10.1002/(sici)1099-0496(199709)24:33.0.co;2-k.
PubMed 9330415Kelleher DC, Merrill CT, Cottrell LT, Nadler EP, Burd RS. Recent national trends in the use of adolescent inpatient bariatric surgery: 2000 through 2009. JAMA Pediatr. 2013 Feb;167(2):126-32. doi: 10.1001/2013.jamapediatrics.286.
PubMed 23247297Kalra M, Inge T, Garcia V, Daniels S, Lawson L, Curti R, Cohen A, Amin R. Obstructive sleep apnea in extremely overweight adolescents undergoing bariatric surgery. Obes Res. 2005 Jul;13(7):1175-9. doi: 10.1038/oby.2005.139.
PubMed 16076986Abu-Abeid S, Gavert N, Klausner JM, Szold A. Bariatric surgery in adolescence. J Pediatr Surg. 2003 Sep;38(9):1379-82. doi: 10.1016/s0022-3468(03)00400-7.
PubMed 14523824Weiner P, Waizman J, Weiner M, Rabner M, Magadle R, Zamir D. Influence of excessive weight loss after gastroplasty for morbid obesity on respiratory muscle performance. Thorax. 1998 Jan;53(1):39-42. doi: 10.1136/thx.53.1.39.
PubMed 9577520Davila-Cervantes A, Dominguez-Cherit G, Borunda D, Gamino R, Vargas-Vorackova F, Gonzalez-Barranco J, Herrera MF. Impact of surgically-induced weight loss on respiratory function: a prospective analysis. Obes Surg. 2004 Nov-Dec;14(10):1389-92. doi: 10.1381/0960892042583996.
PubMed 15603656Santana AN, Souza R, Martins AP, Macedo F, Rascovski A, Salge JM. The effect of massive weight loss on pulmonary function of morbid obese patients. Respir Med. 2006 Jun;100(6):1100-4. doi: 10.1016/j.rmed.2005.09.021. Epub 2005 Oct 21.
PubMed 16243500Nguyen NT, Hinojosa MW, Smith BR, Gray J, Varela E. Improvement of restrictive and obstructive pulmonary mechanics following laparoscopic bariatric surgery. Surg Endosc. 2009 Apr;23(4):808-12. doi: 10.1007/s00464-008-0084-9. Epub 2008 Sep 20.
PubMed 18806943Sahebjami H, Gartside PS. Pulmonary function in obese subjects with a normal FEV1/FVC ratio. Chest. 1996 Dec;110(6):1425-9. doi: 10.1378/chest.110.6.1425.
PubMed 8989055Rubinstein I, Zamel N, DuBarry L, Hoffstein V. Airflow limitation in morbidly obese, nonsmoking men. Ann Intern Med. 1990 Jun 1;112(11):828-32. doi: 10.7326/0003-4819-112-11-828.
PubMed 2378649Hakala K, Mustajoki P, Aittomaki J, Sovijarvi AR. Effect of weight loss and body position on pulmonary function and gas exchange abnormalities in morbid obesity. Int J Obes Relat Metab Disord. 1995 May;19(5):343-6.
PubMed 7647827Thomas PS, Cowen ER, Hulands G, Milledge JS. Respiratory function in the morbidly obese before and after weight loss. Thorax. 1989 May;44(5):382-6. doi: 10.1136/thx.44.5.382.
PubMed 2503905Vaughan RW, Cork RC, Hollander D. The effect of massive weight loss on arterial oxygenation and pulmonary function tests. Anesthesiology. 1981 Apr;54(4):325-8. doi: 10.1097/00000542-198104000-00013.
PubMed 7212333Sugerman HJ, Baron PL, Fairman RP, Evans CR, Vetrovec GW. Hemodynamic dysfunction in obesity hypoventilation syndrome and the effects of treatment with surgically induced weight loss. Ann Surg. 1988 May;207(5):604-13. doi: 10.1097/00000658-198805000-00015.
PubMed 3377570
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Bariatric Surgery Induced Weight Loss on Lung Function in Adolescents
- ClinicalTrials.gov ID
- NCT02644174
- Acronym / sponsor ID
- 0126-16-RMC
- Conditions
- Obesity
- Keywords
- Obesity, Lung function test, Bariatric surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 31 Dec 2015 (estimated)
- 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.
In this prospective study we will evaluate the changes in respiratory physiology occurring in morbidly obese adolescents following bariatric surgery at Schneider Children's Medical Center of Israel (SCMCI).
Detailed description
Morbid obesity leads to restrictive as well as obstructive ventilatory defects via mechanisms that include mechanical, as well as inflammatory factors. We hypothesise that multiple breath nitrogen washout will be more sensitive to changes in small airway function than conventional lung function testing.
We will invite adolescents with morbid obesity, scheduled to undergo bariatric surgery at SCMCI during 2016-2018, for pulmonary function testing, including spirometry, plethysmography, nitrogen multiple breath washout, lung transfer factor and 6 minute walk. These tests will be conducted prior to the operation as well as during follow-up appointments at 3, 6 and 12 months. We will also evaluate oxidative stress using highly sensitive C-reactive protein as surrogate marker.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Adolescents with morbid obesity who will undergo bariatric surgery
Key inclusion criteria (1 listed)
- Adolescents with morbid obesity who will undergo bariatric surgery at the paediatric surgery ward of Schneider Children's Medical Center during 2016-2018
Key exclusion criteria (1 listed)
- Adolescents with background diseases which might influence their ability to conduct pulmonary function tests (for example, patients with neurological disorders)
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 |
|---|---|---|
| Bariatric Surgery | Procedure or surgery | – |
Primary outcome
Change from Baseline Lung Clearance Index
Time frame: 3 months post op
1 secondary outcome
Change from Baseline High sensitivity C reactive protein
Time frame: 3 months post op
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
- Background: PubMed 12651773Li AM, Chan D, Wong E, Yin J, Nelson EA, Fok TF. The effects of obesity on pulmonary function. Arch Dis Child. 2003 Apr;88(4):361-3. doi: 10.1136/adc.88.4.361.
- Background: PubMed 9330415Lazarus R, Colditz G, Berkey CS, Speizer FE. Effects of body fat on ventilatory function in children and adolescents: cross-sectional findings from a random population sample of school children. Pediatr Pulmonol. 1997 Sep;24(3):187-94. doi: 10.1002/(sici)1099-0496(199709)24:33.0.co;2-k.
- Background: PubMed 23247297Kelleher DC, Merrill CT, Cottrell LT, Nadler EP, Burd RS. Recent national trends in the use of adolescent inpatient bariatric surgery: 2000 through 2009. JAMA Pediatr. 2013 Feb;167(2):126-32. doi: 10.1001/2013.jamapediatrics.286.
- Background: PubMed 16076986Kalra M, Inge T, Garcia V, Daniels S, Lawson L, Curti R, Cohen A, Amin R. Obstructive sleep apnea in extremely overweight adolescents undergoing bariatric surgery. Obes Res. 2005 Jul;13(7):1175-9. doi: 10.1038/oby.2005.139.
- Background: PubMed 14523824Abu-Abeid S, Gavert N, Klausner JM, Szold A. Bariatric surgery in adolescence. J Pediatr Surg. 2003 Sep;38(9):1379-82. doi: 10.1016/s0022-3468(03)00400-7.
- Background: PubMed 9577520Weiner P, Waizman J, Weiner M, Rabner M, Magadle R, Zamir D. Influence of excessive weight loss after gastroplasty for morbid obesity on respiratory muscle performance. Thorax. 1998 Jan;53(1):39-42. doi: 10.1136/thx.53.1.39.
- Background: PubMed 15603656Davila-Cervantes A, Dominguez-Cherit G, Borunda D, Gamino R, Vargas-Vorackova F, Gonzalez-Barranco J, Herrera MF. Impact of surgically-induced weight loss on respiratory function: a prospective analysis. Obes Surg. 2004 Nov-Dec;14(10):1389-92. doi: 10.1381/0960892042583996.
- Background: PubMed 16243500Santana AN, Souza R, Martins AP, Macedo F, Rascovski A, Salge JM. The effect of massive weight loss on pulmonary function of morbid obese patients. Respir Med. 2006 Jun;100(6):1100-4. doi: 10.1016/j.rmed.2005.09.021. Epub 2005 Oct 21.
- Background: PubMed 18806943Nguyen NT, Hinojosa MW, Smith BR, Gray J, Varela E. Improvement of restrictive and obstructive pulmonary mechanics following laparoscopic bariatric surgery. Surg Endosc. 2009 Apr;23(4):808-12. doi: 10.1007/s00464-008-0084-9. Epub 2008 Sep 20.
- Background: PubMed 8989055Sahebjami H, Gartside PS. Pulmonary function in obese subjects with a normal FEV1/FVC ratio. Chest. 1996 Dec;110(6):1425-9. doi: 10.1378/chest.110.6.1425.
- Background: PubMed 2378649Rubinstein I, Zamel N, DuBarry L, Hoffstein V. Airflow limitation in morbidly obese, nonsmoking men. Ann Intern Med. 1990 Jun 1;112(11):828-32. doi: 10.7326/0003-4819-112-11-828.
- Background: PubMed 7647827Hakala K, Mustajoki P, Aittomaki J, Sovijarvi AR. Effect of weight loss and body position on pulmonary function and gas exchange abnormalities in morbid obesity. Int J Obes Relat Metab Disord. 1995 May;19(5):343-6.
- Individual participant dataSharing planned: Yes. Peer reviewed journal
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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.
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, run by Rabin Medical Center at 1 site in Israel.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 23 Sep 2021. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick Stafler, MD (972-54-7243623, pstafler@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Lung Clearance Index (time frame: 3 months post op). 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 NCT02644174, which also lists 19 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 23 Sep 2021.