ObesityNCT02421055
Longitudinal Phenotyping of Bariatric Surgery Patients
An observational study of Obesity and Diabetes Mellitus, Type 2, run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Diabetes Mellitus, Type 2
- What is being tested?
- Laparoscopic Roux-en-Y Gastric Bypass and Laparoscopic Sleeve Gastrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 158 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2015to Feb 2019
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with obesity undergoing bariatric surgery
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
This study aims to assess how the gut microbiome affects the host phenotype following bariatric surgery through altered gut microbiome-host co-metabolism. The secondary objective is to identify novel biomarkers for the preoperative prognostication of T2DM remission following bariatric surgery.
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
- Obesity, Diabetes Mellitus, Type 2
- Being tested
- Laparoscopic Roux-en-Y Gastric Bypass, Laparoscopic Sleeve Gastrectomy
- Keywords
- Bariatric Surgery, Gastric Bypass, Sleeve Gastrectomy, Gastroplasty
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Roux-en-Y Gastric BypassProcedure or surgery
Laparoscopic Sleeve GastrectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Roux-en-Y Gastric Bypass Receives: Procedure: Laparoscopic Roux-en-Y Gastric Bypass | |
| Group 2 | Sleeve Gastrectomy Receives: Procedure: Laparoscopic Sleeve Gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Complete Diabetes Remission at 3 Months
Participants with HbA1c <6% (42mmol/mol), off anti-diabetic medication, at 3 months
Measured: 3 months
Secondary outcomes (9)
Partial Diabetes Remission
HbA1c <6.5% (48mmol/mol), off anti-diabetic medication, at 3 months. (Includes participants with complete remission).
Measured: 3 months
HbA1c Improvement
Reduction in HbA1c at 3 months
Measured: 3 months
Weight Loss
Weight loss at 3 months
Measured: 3 months
BMI Reduction
BMI reduction at 3 months
Measured: 3 months
Complete Diabetes Remission
HbA1c <6% (42mmol/mol), off anti-diabetic medication, at 1 year
Measured: 1 year
Partial Diabetes Remission
HbA1c <6.5% (48mmol/mol), off anti-diabetic medication, at 1 year. (Includes participants with complete diabetes remission).
Measured: 1 year
HbA1c Improvement
Reduction in HbA1c at 1 year
Measured: 1 year
Weight Loss
Weight loss at 1 year
Measured: 1 year
BMI Reduction
BMI reduction at 1 year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2015 (estimated)
- Study startJun 2015
- Primary completionFeb 2019
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 158 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ara Darzi, MB, BCh, MD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02421055
- Sponsor's protocol ID
- 15SM2479
- Status last verified
- Oct 2020
- First submitted
- 15 Apr 2015
- Last updated
- 6 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Phenotyping of Bariatric Surgery Patients
- ClinicalTrials.gov ID
- NCT02421055
- Acronym / sponsor ID
- 15SM2479
- Conditions
- Obesity, Diabetes Mellitus, Type 2
- Keywords
- Bariatric Surgery, Gastric Bypass, Sleeve Gastrectomy, Gastroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Feb 2019 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 20 Apr 2015 (estimated)
- Results
- Posted 6 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study aims to assess how the gut microbiome affects the host phenotype following bariatric surgery through altered gut microbiome-host co-metabolism. The secondary objective is to identify novel biomarkers for the preoperative prognostication of T2DM remission following bariatric surgery.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: Laparoscopic Roux-en-Y Gastric BypassRoux-en-Y Gastric Bypass |
| Group 2 | – | Procedure: Laparoscopic Sleeve GastrectomySleeve Gastrectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with obesity undergoing bariatric surgery
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic Roux-en-Y Gastric Bypass | Procedure or surgery | Group 1 |
| Laparoscopic Sleeve Gastrectomy | Procedure or surgery | Group 2 |
Primary outcome
Number of Participants With Complete Diabetes Remission at 3 Months
Time frame: 3 months
Participants with HbA1c <6% (42mmol/mol), off anti-diabetic medication, at 3 months
9 secondary outcomes
Partial Diabetes Remission
Time frame: 3 months
HbA1c Improvement
Time frame: 3 months
Weight Loss
Time frame: 3 months
BMI Reduction
Time frame: 3 months
Complete Diabetes Remission
Time frame: 1 year
Partial Diabetes Remission
Time frame: 1 year
HbA1c Improvement
Time frame: 1 year
Weight Loss
Time frame: 1 year
BMI Reduction
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ara Darzi, MB, BCh, MD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Diabetes Mellitus, Type 2, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Complete Diabetes Remission at 3 Months (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020.