N/A
N=158
Longitudinal Phenotyping of Bariatric Surgery Patients
Obesity · Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT02421055 ↗Enrolled (actual)
158
Serious AEs
—
Results posted
Nov 2020
Primary outcome: Primary: Number of Participants With Complete Diabetes Remission at 3 Months — 8; 5 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Laparoscopic Roux-en-Y Gastric Bypass (Procedure); Laparoscopic Sleeve Gastrectomy (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Complete Diabetes Remission at 3 Months |
8; 5 | — |
| SECONDARY Partial Diabetes Remission |
10; 5 | — |
| SECONDARY HbA1c Improvement |
13.72; 6.88 | — |
| SECONDARY Weight Loss |
37.53; 35.23 | — |
| SECONDARY BMI Reduction |
13.8; 13.02 | — |
| SECONDARY Complete Diabetes Remission |
10; 4 | — |
| SECONDARY Partial Diabetes Remission |
10; 5 | — |
| SECONDARY HbA1c Improvement |
13.72; 6.88 | — |
| SECONDARY Weight Loss |
37.53; 35.23 | — |
| SECONDARY BMI Reduction |
13.8; 13.02 | — |
Summary
Recent studies have shown that bacteria within the gut play an important role in diabetes improvement after bariatric (weight-loss) surgery. Bariatric surgery fundamentally changes the environment within the gut, which results in changes to the makeup of the trillions of bacteria living within it. These changes in the gut bacteria can affect the body in a number of complex ways, which we are only just beginning to understand. For example, gut bacteria breakdown food we are unable to absorb ourselves, leading to altered sugar levels and can release molecules that act to reduce appetite.
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.
Eligibility Criteria
Inclusion Criteria
- Obese (BMI>30kg/m2)
- 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
- Previous bariatric surgery
- 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).
Data sourced from ClinicalTrials.gov (NCT02421055). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.