Impact of Bariatric Surgery on Cardiorespiratory Function

NCT ID: NCT02175810

Last Updated: 2018-05-11

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

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2018-10-31

Brief Summary

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

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.

Detailed Description

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

Conditions

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

Obesity Bariatric Surgery Candidate Physical Activity

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

Eligibility Criteria

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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

Universidade Federal do Triangulo Mineiro

OTHER

Sponsor Role collaborator

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role collaborator

St George's, University of London

OTHER

Sponsor Role lead

Responsible Party

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

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marcia S Volpe

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal Triangulo Mineiro

Dimitra Nikoletou

Role: STUDY_CHAIR

Kingston University and St George's University of London

Marcus Reddy

Role: STUDY_DIRECTOR

St George's Healthcare NHS Trust

Locations

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

St George's Healthcare NHS Trust

London, , United Kingdom

Site Status RECRUITING

Countries

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

United Kingdom

Central Contacts

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

Dimitra Nikoletou, PhD

Role: CONTACT

+44 20 8725 5647

Facility Contacts

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

Dimitra Nikoletou

Role: primary

+44 20 8725 5647

Other Identifiers

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

13.0217

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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

Study of Bariatric Surgery
NCT02857179 RECRUITING
The Bariatric Surgery Registry
NCT03441451 RECRUITING