ObesityNCT02175810
Impact of Bariatric Surgery on Cardiorespiratory Function
An observational study of Obesity and Bariatric Surgery Candidate, run by St George's, University of London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Obesity, Bariatric Surgery Candidate, Physical Activity
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2014to Oct 2018
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with scheduled bariatric surgery at St George's Healthcare NHS Trust.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
St George's Healthcare NHS Trust
London, SW17 0RE
Dimitra Nikoletou, +44 20 8725 5647, dinikole@sgul.ac.uk
Emma R McGlone
About this study
Official title: Impact of Bariatric Surgery on Cardiorespiratory Function: an Observational Study
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.
- Conditions
- Obesity, Bariatric Surgery Candidate, Physical Activity
- Keywords
- Obesity, Bariatric surgery, physical activity, cardiopulmonary exercise test
- Medical subject headings
- Obesity, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorespiratory function assessed by peak oxygen consumption (VO2peak)
Measured: One to two weeks before surgery and six months after surgery
Secondary outcomes (5)
Lung function
Lung function will be assessed by spirometry and body plethysmography
Measured: One to two weeks before surgery and six months after surgery
Heart function
Echocardiography will be performed to assess heart function.
Measured: One to two weeks before surgery and six months after surgery
Inspiratory muscle strength
Maximal inspiratory pressure and sniff nasal pressure will be recorded.
Measured: One to two weeks before surgery and six months after surgery
Peripheral muscle strength
Maximum isometric strength of hand/ forearm, quadriceps and hip flexors muscles will be evaluated
Measured: One to two weeks before surgery and six months after surgery
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.
Measured: One to two weeks before surgery and six months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionOct 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Federal do Triangulo Mineiro, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Sponsor
- Investigators
- Marcia S Volpe, Principal investigator, Universidade Federal Triangulo MineiroDimitra Nikoletou, Study chair, Kingston University and St George's University of LondonMarcus Reddy, Study director, St George's Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02175810
- Sponsor's protocol ID
- 13.0217
- Status last verified
- May 2018
- First submitted
- 25 Jun 2014
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Bariatric Surgery on Cardiorespiratory Function: an Observational Study
- ClinicalTrials.gov ID
- NCT02175810
- Acronym / sponsor ID
- 13.0217
- Conditions
- Obesity, Bariatric Surgery Candidate, Physical Activity
- Keywords
- Obesity, Bariatric surgery, physical activity, cardiopulmonary exercise test
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Collaborators
- Universidade Federal do Triangulo Mineiro, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Jun 2014
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 26 Jun 2014 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with scheduled bariatric surgery at St George's Healthcare NHS Trust.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiorespiratory function assessed by peak oxygen consumption (VO2peak)
Time frame: One to two weeks before surgery and six months after surgery
5 secondary outcomes
Lung function
Time frame: One to two weeks before surgery and six months after surgery
Heart function
Time frame: One to two weeks before surgery and six months after surgery
Inspiratory muscle strength
Time frame: One to two weeks before surgery and six months after surgery
Peripheral muscle strength
Time frame: One to two weeks before surgery and six months after surgery
Free living sedentary and physical activity times
Time frame: One to two weeks before surgery and six months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
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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.
Marcia S Volpe principal investigator
Universidade Federal Triangulo Mineiro
Dimitra Nikoletou study chair
Kingston University and St George's University of London
Marcus Reddy study director
St George's Healthcare NHS Trust
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 and Bariatric Surgery Candidate, run by St George's, University of London at 1 site in United Kingdom.
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 2 inclusion and 4 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 11 May 2018. 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 United Kingdom. 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 Dimitra Nikoletou, PhD (+44 20 8725 5647, dinikole@sgul.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiorespiratory function assessed by peak oxygen consumption (VO2peak) (time frame: One to two weeks before surgery and six months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2018.