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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02644174
• Other study ID #: 0126-16-RMC
• Status: Recruiting
• Start date: May 2016
• Est. completion date: January 2023

Study information

• Verified date: September 2021
• Source: Rabin Medical Center
• Contact: Patrick Stafler, MD
• Phone: 972-54-7243623
• Email: pstafler[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Procedure:
• Bariatric Surgery

Locations

Country	Name	City	State
Israel	Schneider Children's Medical Center of Israel	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (19)

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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. — View Citation

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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. Epub 2005 Oct 21. — View Citation

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* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Lung Clearance Index		3 months post op
Secondary	Change from Baseline High sensitivity C reactive protein		3 months post op