- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02175810
Impact of Bariatric Surgery on Cardiorespiratory Function
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.
Studienübersicht
Status
Studientyp
Einschreibung (Voraussichtlich)
Kontakte und Standorte
Studienorte
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London, Vereinigtes Königreich, SW17 0RE
- Rekrutierung
- St George's Healthcare NHS Trust
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Kontakt:
- Dimitra Nikoletou
- Telefonnummer: +44 20 8725 5647
- E-Mail: dinikole@sgul.ac.uk
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Unterermittler:
- Emma R McGlone
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Unterermittler:
- Ommar A Khan
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Cardiorespiratory function assessed by peak oxygen consumption (VO2peak)
Zeitfenster: One to two weeks before surgery and six months after surgery
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One to two weeks before surgery and six months after surgery
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Lung function
Zeitfenster: One to two weeks before surgery and six months after surgery
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Lung function will be assessed by spirometry and body plethysmography
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One to two weeks before surgery and six months after surgery
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Heart function
Zeitfenster: One to two weeks before surgery and six months after surgery
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Echocardiography will be performed to assess heart function.
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One to two weeks before surgery and six months after surgery
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Inspiratory muscle strength
Zeitfenster: One to two weeks before surgery and six months after surgery
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Maximal inspiratory pressure and sniff nasal pressure will be recorded.
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One to two weeks before surgery and six months after surgery
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Peripheral muscle strength
Zeitfenster: One to two weeks before surgery and six months after surgery
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Maximum isometric strength of hand/ forearm, quadriceps and hip flexors muscles will be evaluated
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One to two weeks before surgery and six months after surgery
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Free living sedentary and physical activity times
Zeitfenster: One to two weeks before surgery and six months after surgery
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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.
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One to two weeks before surgery and six months after surgery
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Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Marcia S Volpe, Universidade Federal Triangulo Mineiro
- Studienstuhl: Dimitra Nikoletou, Kingston University and St George's University of London
- Studienleiter: Marcus Reddy, St George's Healthcare NHS Trust
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 13.0217
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