NCT02421055

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 20, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

November 6, 2020

Completed
Last Updated

November 6, 2020

Status Verified

October 1, 2020

Enrollment Period

3.7 years

First QC Date

April 15, 2015

Results QC Date

August 11, 2020

Last Update Submit

October 15, 2020

Conditions

ObesityDiabetes Mellitus, Type 2

Keywords

Bariatric SurgeryGastric BypassSleeve GastrectomyGastroplasty

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Complete Diabetes Remission at 3 Months

    Participants with HbA1c \<6% (42mmol/mol), off anti-diabetic medication, at 3 months

    3 months

Secondary Outcomes (9)

  • Partial Diabetes Remission

    3 months

  • HbA1c Improvement

    3 months

  • Weight Loss

    3 months

  • BMI Reduction

    3 months

  • Complete Diabetes Remission

    1 year

  • +4 more secondary outcomes

Study Arms (2)

Group 1

Roux-en-Y Gastric Bypass

Procedure: Laparoscopic Roux-en-Y Gastric Bypass

Group 2

Sleeve Gastrectomy

Procedure: Laparoscopic Sleeve Gastrectomy

Interventions

Laparoscopic Roux-en-Y Gastric BypassPROCEDURE
Group 1
Laparoscopic Sleeve GastrectomyPROCEDURE
Group 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants with obesity undergoing bariatric surgery

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial Weight Centre

London, W2 1NY, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum, urine and stool preoperatively and at 3 months and 1 year postoperatively.

MeSH Terms

Conditions

ObesityDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Limitations and Caveats

Complete sets of serum, 24-hour urine and faeces were not collected from all participants. Details are described in baseline group descriptions.

Results Point of Contact

Title
Dr Nicholas Penney
Organization
Imperial College London
n.penney@imperial.ac.uk
020 7589 5111

Study Officials

  • Ara Darzi, MB, BCh, MD

    Imperial College London

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2015

First Posted

April 20, 2015

Study Start

June 1, 2015

Primary Completion

February 1, 2019

Study Completion

February 1, 2019

Last Updated

November 6, 2020

Results First Posted

November 6, 2020

Record last verified: 2020-10

Locations

GB(1)