Condition category
Digestive System
Date applied
30/01/2017
Date assigned
03/02/2017
Last edited
09/11/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
It is widely acknowledged that surgery on the gastrointestinal tract (gut), particularly the stomach and oesophagus (gullet), changes the way the body senses and processes food. While undergoing these procedures can prove beneficial, in many cases patients suffer problematic symptoms after surgery. These particularly include the “dumping syndrome”, where a person may feel flushed, faint or even pass out after a meal. Some believe that these symptoms are caused by an overactive response of certain cells in the lining of the gut to food. These cells produce chemical signals (hormones) which would normally tell the body how much food has been eaten, and how to deal with it. When too much of one of these hormones is produced, the body can react badly and make someone unwell. This study aims to understand what hormones are altered by surgery, why this happens and how the impact of this problem in people can be reduced in people who have had surgery on their gastrointestinal tract.

Who can participate?
Healthy volunteers, and adults who have undergone, or are due to undergo, surgery to remove all or part of the stomach or oesophagus.

What does the study involve?
All participants are asked to complete questionnaires and attend for a sugar drink test, during which their blood sugar levels are monitored by taking ans testing blood samples. Smaller groups of participants who have had surgery are invited to participate in more detailed studies, including identification and treatment of altered levels of bacteria in the small intestine, continuous glucose monitoring (continuously measuring blood sugar levels using a special device that is worn on the body) in the community and collection of tissue biopsies (samples) during surgery or subsequent endoscopy.

What are the possible benefits and risks of taking part?
After surgery, patients will benefit from having the opportunity to explore their altered eating habits and associated symptoms in a controlled environment. This is a very poorly understood field, and it is hoped that by defining the problems experienced by this group researchers can start to explore novel treatment strategies in the future. There are rare risks associated with taking part, during the glucose tolerance test there is a risk of feeling unwell and transient low blood sugar levels, endoscopy carries risks of bleeding or damage to the bowel but these are both very unlikely.

Where is this study run from?
Addenbrooke’s Hospital (UK)

When is the study starting and how long is it expected to run for?
July 206 to October 2021

Who is funding the study:
1. National Institute of Health Research (UK)
2. Wellcome Trust (UK)
3. Medical Research Council (UK)

Who is the main contact?
Mr Geoffrey Roberts
gpr25@cam.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Mr Geoffrey Roberts

ORCID ID

http://orcid.org/0000-0001-9554-8404

Contact details

Addenbrooke's Hospital
Box 289
Hills Road
Cambridge
CB2 0QQ
United Kingdom
+44 1223 767176
gpr25@cam.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

33469

Study information

Scientific title

The metabolic consequences of gastrointestinal surgery

Acronym

Study hypothesis

The aim of this study is to evaluate the the metabolic consequences of surgery, define new approaches to the diagnosis and management of dumping syndrome, and improve knowledge of human gastrointestinal and metabolic physiology.

Ethics approval

East of England – Cambridge South REC, 28/11/2016, ref: 16/EE/0338

Study design

Non-randomised; Both; Design type: Treatment, Drug, Cohort study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See additional files

Condition

Specialty: Gastroenterology, Primary sub-specialty: Gastroenterology; UKCRC code/ Disease: Oral and Gastrointestinal/ Other diseases of the digestive system, Metabolic and Endocrine/ Other nutritional deficiencies

Intervention

A cohort of patients who have undergone surgery on the stomach or oesophagus will be recruited to undergo cognitive (questionnaire) and metabolic (oral glucose tolerance test) assessment. If recruited within two years of surgery, the participant will complete questionnaires at 3, 6, 12 and 24 months post-surgery. If greater than two years post-surgery participants will complete a single assessment.

A subset of up to 15 participants identified with small intestinal bacterial overgrowth on hydrogen / methane breath testing will be treated with Rifaximin 400mg TDS for 7 days and then have a repeat oral glucose tolerance test. This is an open label study to assess the effect of treatment of bacterial overgrowth (common in this group) on secretion of gut derived hormones and metabolic indices / glucose metabolism.

A subset of up to 15 participants identified with severe metabolic complications of surgery and deranged gut hormone secretion will receive a single dose of 50 micrograms of subcutaneous octreotide immediately prior to a repeat glucose tolerance test to assess the effects of gut hormone suppression on metabolic indices and glucose metabolism.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Plasma glucose is measured by the hexokinase method at 15, 30, 45, 60, 90, 120, 150 and 180 minutes post 50g glucose tolerance test.

Secondary outcome measures

1. Plasma Insulin is measured by sandwich ELISA at 15, 30, 45, 60, 90, 120, 150 and 180 minutes post 50g glucose tolerance test
2. Plasma total GLP-1 is measured by MSD sandwich ELISA at 15, 30, 45, 60, 90, 120, 150 and 180 minutes post 50g glucose tolerance test
3. Hunger and fullness are measured by visual analogue scales (range 0-100) at 15, 30, 45, 60, 90, 120, 150 and 180 minutes post 50g glucose tolerance test

Overall trial start date

07/07/2016

Overall trial end date

01/10/2021

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 years and over
2. Capacity to give voluntary informed consent
3. Undergone, or have planned within the next 12 months, surgery including removal of all or part of the stomach or oesophagus; or be a carrier of a genetic mutation conferring a high risk of requiring a future prophylactic gastrectomy

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 200; UK Sample Size: 200

Participant exclusion criteria

All participants:
1. Aged under 18 years
2. Recent history of untreated anaemia
3. Lack capacity to read and retain information about the study
4. Communication issues which prevent accurate understanding of the study rationale and requirements

Post-operative participants:
1. Recurrent gastric or oesophageal cancer

Participants for endoscopy:
1. Contraindication to upper gastrointestinal endoscopy
2. Taking medication that would pose a significant risk of haemorrhage after biopsy (e.g. Clopidogrel, Warfarin, Dipyridamole, novel oral antigoagulants, therapeutic dose heparin)
3. Significant medical comorbidity that may be adversely effected by endoscopy or sedation (e.g. unstable ischaemic heart disease, significant respiratory impairment)

Participants for physiological challenge with antibiotics or Somatostatin analogue:
1. Known allergy to the proposed agent
2. Received a course of antibiotics in the preceding two months
3. Suffer from a known illness that may be exacerbated by the proposed agent
4. Be on medication which interacts with the proposed agent

Recruitment start date

16/01/2017

Recruitment end date

01/10/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Organisation

Cambridge University Hospitals NHS Foundation Trust

Sponsor details

Box 277
Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
+44 1223 217418
R&denquiries@addenbrookes.nhs.uk

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

Funder name

Wellcome Trust

Alternative name(s)

Wellcome

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

United Kingdom

Funder name

Medical Research Council

Alternative name(s)

MRC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal: interim findings 2018, final findings 2022.

IPD Sharing plan:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication - it is anticipated that full datasets will be made available through the University of Cambridge data repository.

Intention to publish date

31/12/2022

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Editorial Notes

09/11/2017: The ISRCTN prospective/retrospective flag compares the date of registration with the recruitment start date and does not include any grace period. The registration of this study was requested through the NIHR Portfolio and was finalised within 6 months of the recruitment starting.