Clinical trial NCT02644174: The Impact of Bariatric Surgery Induced Weight Loss on Lung Function in Adolescents
Official title: The Impact of Bariatric Surgery Induced Weight Loss on Lung Function in Adolescents
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Keywords: Obesity
Lung function test
Bariatric surgery
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2015-12-31
Enrollment: 60
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adolescents with morbid obesity who will undergo bariatric surgery

Brief 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).

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change from Baseline Lung Clearance Index
timeFrame: 3 months post op
Secondary outcomes:
measure: Change from Baseline High sensitivity C reactive protein
timeFrame: 3 months post op
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Schneider Children's Medical Center of Israel
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.