Condition category
Nutritional, Metabolic, Endocrine
Date applied
29/07/2015
Date assigned
30/07/2015
Last edited
12/02/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Obesity is the main cause of the world wide epidemic of diabetes. Weight loss, or bariatric, surgery produces major and sustained weight loss and is being increasingly used to treat obese diabetic patients. There was initial optimism that these procedures might cure all diabetes. However, the gold-standard operation, standard gastric bypass, effectively cures diabetes in only 4 out of 10 patients. To design a safer and more successful procedure we need to understand how bariatric surgery works to improve diabetes. Hormones from the gut are released when we eat food. They control how the body uses the food it absorbs. For example they release the sugar lowering hormone insulin, and also greatly reduce appetite, which is why one feels less hungry after eating a meal. We have discovered that the good effects of bariatric surgery, and in particular the gastric bypass, are mainly due to increased release of gut hormones, reducing patients appetite and improving the release of insulin. In this project we will be testing a new procedure called the long-limb gastric bypass. It is designed particularly to be better at helping the diabetes in overweight patients, while being as safe as the currently available standard gastric bypass. We now want to show that this new procedure works better than the standard gastric bypass by causing an even bigger increase in the release of gut hormones and therefore insulin.

Who can participate?
Obese adults (aged 18-70) with type 2 diabetes.

What does the study involve?
Participants are randomly assigned into one of two groups. Those in group 1 have a standard-limb gastric bypass. Those in group 2 have a long-limb gastric bypass. Using a newly developed technique (mass spectroscopy) we then measure the differences in gut hormone secretion between the new long-limb and the standard gastric bypass. We also use a well-tested insulin sensitivity procedure (glucose clamp), both to confirm and to investigate how and why each participants diabetes has improved after the surgery.

What are the possible benefits and risks of participating?
The measurements we will be making are non-invasive and safe. The only discomfort comes from inserting a cannula to take blood samples.

Where is the study run from?
Imperial College London, Hammersmith Hospital (lead centre) and King’s College London (UK)

When is the study starting and how long is it expected to run for?
August 2015 to February 2018

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Alex Miras

Trial website

Contact information

Type

Public

Primary contact

Dr Alex Miras

ORCID ID

http://orcid.org/0000-0003-3830-3173

Contact details

Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

19153

Study information

Scientific title

Are gut hormone changes the reason why the long-limb gastric bypass is more effective than the standard limb gastric bypass in improving type 2 diabetes mellitus? A randomised controlled trial

Acronym

LONG LIMB

Study hypothesis

The aim of this study is to show that a new bariatric surgery, the long-limb gastric bypass, is more effective at treating diabetes in people with obesity than the standard-limb gastric bypass.

Ethics approval

West London & GTAC, 29/06/2015, ref: 15/LO/0813

Study design

Randomised; Double blind; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Topic: Diabetes; Subtopic: Type 2; Disease: Diabetic Control, Obesity

Intervention

Bariatric surgery, either the standard-­limb or long­-limb gastric bypass
Study Entry : Registration and one or more randomisations

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Change in peak GLP-­1 level; Timepoint(s): After the mixed meal tolerance test.

Secondary outcome measures

1. Plasma levels of glucose, insulin, c-peptide, gut hormones, bile acids, FGF-19 and 21 after the mixed meal tolerance test
2. Rate of glucose appearance (Ra) and disposal (Rd) in the euglycaemic hyperinsulinaemic clamp
3. Faecal caloric content
4. Blood, urine and faecal microbial diversity and metabolomics
5. Total caloric intake and macronutrient composition
6. HbA1c
7. Total number of medications
8. Rates of patients achieving diabetes remission
9. Body weight
10. Systolic, diastolic blood pressure and pulse
11. Serum fasting lipids
12. Medical, surgical, nutritional and psychological complications
13. Adverse events

Overall trial start date

01/02/2015

Overall trial end date

14/08/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Both genders
2. Age 18-70
3. Type 2 diabetes mellitus
4. Obesity
5. HbA1c>7.0%
6. On glucose-lowering medication

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 50; UK Sample Size: 50

Participant exclusion criteria

1. Contraindications to bariatric surgery
2. Type 1 diabetes
3. Pregnancy or breastfeeding
4. Recent blood donation

Recruitment start date

31/07/2015

Recruitment end date

01/02/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Imperial College London, Hammersmith Hospital (lead centre)
Du Cane Road
London
W12 0NN
United Kingdom

Trial participating centre

King’s College London
Denmark Hill
London
SE5 9RS
United Kingdom

Sponsor information

Organisation

Imperial College London

Sponsor details

Joint Research Compliance Office
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The results of this project will be published in high quality peer-reviewed journals with a wide medical and scientific readership which will allow the detail of the trial to be scrutinized by the medical and scientific community at large. The results of the study will be presented at national and international scientific meetings. All of the applicants are experts in their field and regularly lecture to professional and lay audiences on these topics. We will also disseminate our findings via the press offices of Imperial College London and King’s College London and associated NHS Trusts. Crucially, the clinical results of the trial will be disseminated through our research teams and institutions to NHS England service providers and policymakers.

Intention to publish date

01/02/2019

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

12/02/2016: Amended study design by adding the text "Double blind"