Impact of Bariatric Surgery on Cardiorespiratory Function

Obesity Clinical Trial

Official title:

Impact of Bariatric Surgery on Cardiorespiratory Function: an Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02175810
• Other study ID #: 13.0217
• Status: Recruiting
• Start date: June 2014
• Est. completion date: October 2018

Study information

• Verified date: May 2018
• Source: St George's, University of London
• Contact: Dimitra Nikoletou, PhD
• Phone: +44 20 8725 5647
• Email: dinikole[@]sgul.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Obesity is a growing problem worldwide and its prevention has become one of the leading priorities for the World Health Organisation. Obesity results from chronic imbalance between energy intake and energy expenditure. Although early prevention of obesity is preferable, surgical treatment is often required for severely obese people.

Bariatric surgery has been shown to be the most effective therapy for severe obesity. Weight loss following bariatric surgery results in significant improvements in coexisting comorbidities, such as diabetes and hypertension but there is controversy whether bariatric surgery also improves aerobic capacity.

The purpose of this study is to investigate the effects of bariatric surgery on cardiopulmonary function and on daily physical activity. It is hypothesized that bariatric surgery will improve aerobic capacity and result in beneficial lifestyle changes from sedentary to more active.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Ages 18 years to 50 years

• Patients enrolled in the bariatric surgery program of St George's Hospital with BMI > 40 kg/m2, or 35-40 kg/m2 in the presence of other obesity-related comorbidities such as hypertension or type- 2 diabetes

Exclusion Criteria:

• Locomotor difficulties which would prevent participants from completing the cardiopulmonary exercise testing

• Weight > 190 kg (due to weight restrictions of equipment used to transfer patients in the event of medical emergencies)

• Cognitive impairment

• Patients unable to follow instructions in English

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Obesity
• Physical Activity

Locations

Country	Name	City	State
United Kingdom	St George's Healthcare NHS Trust	London

Sponsors (3)

Lead Sponsor	Collaborator
St George's, University of London	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Universidade Federal do Triangulo Mineiro

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiorespiratory function assessed by peak oxygen consumption (VO2peak)		One to two weeks before surgery and six months after surgery
Secondary	Lung function	Lung function will be assessed by spirometry and body plethysmography	One to two weeks before surgery and six months after surgery
Secondary	Heart function	Echocardiography will be performed to assess heart function.	One to two weeks before surgery and six months after surgery
Secondary	Inspiratory muscle strength	Maximal inspiratory pressure and sniff nasal pressure will be recorded.	One to two weeks before surgery and six months after surgery
Secondary	Peripheral muscle strength	Maximum isometric strength of hand/ forearm, quadriceps and hip flexors muscles will be evaluated	One to two weeks before surgery and six months after surgery
Secondary	Free living sedentary and physical activity times	Daily physical activity habits will be assessed by an accelerometer and International Physical Activity Questionnaire: Long (IPAQ-Long). Participants will be required to wear the accelerometer for four consecutive days during the two study points.	One to two weeks before surgery and six months after surgery