Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
158 participants
OBSERVATIONAL
2015-06-30
2019-02-28
Brief Summary
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In this study we aim to find out how bariatric surgery changes the gut bacteria and how this leads to weight loss and improvement of diabetes. With this understanding we hope to discover potential targets for future treatments, such as identifying beneficial bacteria that could be supplemented with probiotics in patients.
Additionally, although highly successful, up to 30% of obese patients do not undergo improvement of their diabetes after bariatric surgery. We aim to identify molecules within the patient's blood or urine that are able to predict the likely chance a patient will undergo improvement in their diabetes after bariatric surgery to help clinicians select patients most likely to benefit.
Detailed Description
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The study will longitudinally phenotype obese diabetics and non-diabetics undergoing Roux-en-Y Gastric Bypass or Sleeve Gastrectomy surgery. Patients will be assessed preoperatively and at 3 months and 1 year postoperatively. Clinical measures recorded will include; 1) anthropometric \& physiological measurements, 2) demographic details, 3) biochemical parameters including HbA1c, 4) anti-hyperglycaemic and other medication use, 5) co-morbidity status and 6) dietary choices through 24hr dietary recall questionnaires.
Blood, urine and stool samples will be collected at the above time points. Changes to the microbiome will be assessed using metagenomic sequencing. Global metabonomic profiles of serum, urine and faecal water will be generated using 1H-NMR. Further targeted analyses of bile acid and short-chain fatty acid profiles will be performed using LC-MS / GC-MS.
The study will utilise multivariate statistical analysis techniques to identify metabolic pathways altered following intervention, and novel host-microbiome co-metabolism pathways that impact upon phenotype. A supervised multivariate analysis, mapping T2DM outcomes to metagenomic and metabonomic data will be performed with the aim of identifying novel preoperative biomarkers that are able to prognosticate T2DM resolution following bariatric surgery.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group 1
Roux-en-Y Gastric Bypass
Laparoscopic Roux-en-Y Gastric Bypass
Group 2
Sleeve Gastrectomy
Laparoscopic Sleeve Gastrectomy
Interventions
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Laparoscopic Roux-en-Y Gastric Bypass
Laparoscopic Sleeve Gastrectomy
Eligibility Criteria
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Inclusion Criteria
* Type 2 Diabetes Mellitus and non-diabetic
* Failure of efforts at lifestyle modification and dieting
* Fitness for anaesthesia and procedure
* Willingness to comply with the trial protocol
Exclusion Criteria
* Pregnancy or intention to become pregnant during trial period
* Lack of capacity to consent
* Previous major abdominal surgery (Small or large bowel resection, stomach, liver, pancreatic or splenic surgery. Does not include patients who have previously had an appendicectomy, cholecystectomy or hernia repair).
18 Years
ALL
No
Sponsors
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Imperial College London
OTHER
Responsible Party
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Principal Investigators
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Ara Darzi, MB, BCh, MD
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Locations
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Imperial Weight Centre
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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15SM2479
Identifier Type: -
Identifier Source: org_study_id