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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Mr
James
O'Brien
james.obrien1@nhs.net
Dr
Adam
Frampton
adam.frampton@surrey.ac.uk
Obesity and other hyperalimentation
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Bariatric surgery is established as an effective treatment for obesity that consistently results in significant weight loss and an improvement in the co-morbidities associated with metabolic disease, such as hypertension, type two diabetes and fatty liver. With an increasing incidence of obesity worldwide, the total number of bariatric procedures performed looks set to increase. UK registries report the majority of patients undergo sleeve gastrectomy (42.5% in 2018). The mechanism of action of surgery, thought to involve gastrointestinal permeability (gut wall “leakiness”), the microbiome, diet, anatomical and neuro-entero-hormonal change, is poorly understood. Gut permeability has been identified as a critical component of the metabolic change that follows surgery, supported by non-bariatric studies showing that intestinal permeability is associated with obesity, is increased in diabetics and persists even when BMI is controlled. There are a small number of studies around permeability after bariatric surgery, and the published literature shows conflicting results. By studying consenting adult patients undergoing surgery at St Richard's Hospital, we aim to increase understanding of permeability before and after sleeve gastrectomy, and investigate further any association with fatty liver disease and colonic change, through analysis of urinary permeability samples, diet, liver biopsy and markers in blood and urinary samples. Sampling will be in addition to routine care samples, but taken at the same time, in order to minimise patient discomfort and inconvenience. Each patient will collect urinary permeability samples at home, the day before a routine clinical interaction, so there are no unnecessary visits to hospital to return the urine samples. Sampling will be repeated four times over a total of 12 months of study, and requires no deviation from standard care.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Observational type: Cohort study;
You can take part if:
You may not be able to take part if:
• Unwilling or unable to provide written informed consent, or withdrawal of consent (written or verbal/ failure to attend) • Non-English speaking • Aged < 18 years • The bariatric multidisciplinary team screen for mental health illness contraindicating bariatric surgery routinely. Significant mental health co-morbidity – weight loss and outcomes following bariatric surgery are shown to be associated with pre-operative mental health diagnosis and it is unclear whether surgery improves pre-existing mental health conditions. Bariatric surgery can pose a significant psychological challenge to patients therefore it is not ethical to recruit patients with a major pre-operative psychiatric diagnosis. Each patient is under the care of a clinical psychologist throughout the normal treatment pathway. • Procedure planned other than sleeve gastrectomy • Intra-operative conversion from sleeve gastrectomy to Roux-en-Y gastric bypass or other procedure The following all confound assessment of gastrointestinal permeability due to known impact on gastrointestinal motility, absorption and inflammation: • Smoking • Use of antibiotics in the previous 3 months • Pregnancy or breast feeding • History of inflammatory bowel disease • History of previous major small intestinal or colonic surgery • Cirrhosis or liver failure • Alcohol consumption > 20 units/ week • Nephrotic syndrome or chronic renal failure (whilst not stated in the permeability literature, eGFR< 60 is the internationally agreed upper range suggestive of kidney impairment) • Thyroid disease - confounds assessment of gastrointestinal permeability • History of small intestinal bacterial overgrowth • Major post-operative complication(s) (Classified as Clavien-Dindo score > = 2)
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by University of Surrey and funded by Royal College of Surgeons of England; ROYAL SURREY COUNTY HOSPITAL NHS FOUNDATION TRUST; .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 50797
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