- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
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London, Storbritannia, SW17 0RE
- Rekruttering
- St George's Healthcare NHS Trust
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Ta kontakt med:
- Dimitra Nikoletou
- Telefonnummer: +44 20 8725 5647
- E-post: dinikole@sgul.ac.uk
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Underetterforsker:
- Emma R McGlone
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Underetterforsker:
- Ommar A Khan
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Cardiorespiratory function assessed by peak oxygen consumption (VO2peak)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Lung function
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Marcia S Volpe, Universidade Federal Triangulo Mineiro
- Studiestol: Dimitra Nikoletou, Kingston University and St George's University of London
- Studieleder: Marcus Reddy, St George's Healthcare NHS Trust
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 13.0217
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