The Impact of Bariatric Surgery Induced Weight Loss on Lung Function in Adolescents

NCT ID: NCT02644174

Last Updated: 2021-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Study Completion Date

2023-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bariatric Surgery

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adolescents with morbid obesity who will undergo bariatric surgery at the paediatric surgery ward of Schneider Children's Medical Center during 2016-2018

Exclusion Criteria

* Adolescents with background diseases which might influence their ability to conduct pulmonary function tests (for example, patients with neurological disorders)
Minimum Eligible Age

11 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Rabin Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Patrick Stafler

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Schneider Children's Medical Center of Israel

Petah Tikva, , Israel

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Israel

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Patrick Stafler, MD

Role: CONTACT

972-54-7243623

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Patrick Stafler, MD

Role: primary

972547243623

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 12651773 (View on PubMed)

Lazarus 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.

Reference Type BACKGROUND
PMID: 9330415 (View on PubMed)

Kelleher 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.

Reference Type BACKGROUND
PMID: 23247297 (View on PubMed)

Kalra 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.

Reference Type BACKGROUND
PMID: 16076986 (View on PubMed)

Abu-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.

Reference Type BACKGROUND
PMID: 14523824 (View on PubMed)

Weiner 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.

Reference Type BACKGROUND
PMID: 9577520 (View on PubMed)

Davila-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.

Reference Type BACKGROUND
PMID: 15603656 (View on PubMed)

Santana 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.

Reference Type BACKGROUND
PMID: 16243500 (View on PubMed)

Nguyen 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.

Reference Type BACKGROUND
PMID: 18806943 (View on PubMed)

Sahebjami 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.

Reference Type BACKGROUND
PMID: 8989055 (View on PubMed)

Rubinstein 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.

Reference Type BACKGROUND
PMID: 2378649 (View on PubMed)

Hakala 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.

Reference Type BACKGROUND
PMID: 7647827 (View on PubMed)

Thomas 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.

Reference Type BACKGROUND
PMID: 2503905 (View on PubMed)

Vaughan 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.

Reference Type BACKGROUND
PMID: 7212333 (View on PubMed)

Sugerman 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.

Reference Type BACKGROUND
PMID: 3377570 (View on PubMed)

Boone KA, Cullen JJ, Mason EE, Scott DH, Doherty C, Maher JW. Impact of Vertical Banded Gastroplasty on Respiratory Insufficiency of Severe Obesity. Obes Surg. 1996 Dec;6(6):454-458. doi: 10.1381/096089296765556322.

Reference Type BACKGROUND
PMID: 10729891 (View on PubMed)

Scheuller M, Weider D. Bariatric surgery for treatment of sleep apnea syndrome in 15 morbidly obese patients: long-term results. Otolaryngol Head Neck Surg. 2001 Oct;125(4):299-302. doi: 10.1067/mhn.2001.119139.

Reference Type BACKGROUND
PMID: 11593162 (View on PubMed)

Dixon JB, Schachter LM, O'Brien PE. Polysomnography before and after weight loss in obese patients with severe sleep apnea. Int J Obes (Lond). 2005 Sep;29(9):1048-54. doi: 10.1038/sj.ijo.0802960.

Reference Type BACKGROUND
PMID: 15852048 (View on PubMed)

Aaron SD, Fergusson D, Dent R, Chen Y, Vandemheen KL, Dales RE. Effect of weight reduction on respiratory function and airway reactivity in obese women. Chest. 2004 Jun;125(6):2046-52. doi: 10.1378/chest.125.6.2046.

Reference Type BACKGROUND
PMID: 15189920 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0126-16-RMC

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Registry on Obesity Surgery in Adolescents
NCT03203161 NOT_YET_RECRUITING
Bariatric Surgeries in Elderly
NCT02817295 COMPLETED