ISRCTN ISRCTN39435140
DOI https://doi.org/10.1186/ISRCTN39435140
ClinicalTrials.gov number NCT02836353
Secondary identifying numbers 33469
Submission date
30/01/2017
Registration date
03/02/2017
Last edited
16/01/2020
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Mr Geoffrey Roberts
Public

Addenbrooke's Hospital
Box 289
Hills Road
Cambridge
CB2 0QQ
United Kingdom

ORCiD logoORCID ID 0000-0001-9554-8404
Phone +44 1223 767176
Email gpr25@cam.ac.uk

Study information

Study designNon-randomised; Both; Design type: Treatment, Drug, Cohort study
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet ISRCTN39435140_PIS_11Nov16_V3_SurgicalPatient.pdf
Scientific titleThe metabolic consequences of gastrointestinal surgery
Study objectivesThe 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(s)East of England – Cambridge South REC, 28/11/2016, ref: 16/EE/0338
Health condition(s) or problem(s) studiedGastrointestinal surgery
InterventionA 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 typeOther
Primary outcome measurePlasma 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 measures1. 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 study start date07/07/2016
Completion date01/10/2021
Reason abandoned (if study stopped)Objectives no longer viable

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsPlanned Sample Size: 200; UK Sample Size: 200
Key inclusion criteria1. 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
Key exclusion criteriaAll 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
Date of first enrolment16/01/2017
Date of final enrolment01/10/2020

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

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

Sponsor information

Cambridge University Hospitals NHS Foundation Trust
Hospital/treatment centre

Box 277
Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
England
United Kingdom

Phone +44 1223 217418
Email R&denquiries@addenbrookes.nhs.uk
ROR logo "ROR" https://ror.org/04v54gj93

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government
Alternative name(s)
National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location
United Kingdom
Wellcome Trust
Private sector organisation / International organizations
Location
United Kingdom
Medical Research Council
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

Results and Publications

Intention to publish date31/12/2022
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryStored in repository
Publication and dissemination planPlanned publication in a high-impact peer reviewed journal: interim findings 2018, final findings 2022.
IPD sharing planThe 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.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet version V3 11/11/2016 03/02/2017 No Yes
Participant information sheet version V2 19/09/2016 03/02/2017 No Yes
HRA research summary 28/06/2023 No No

Additional files

ISRCTN39435140_PIS_11Nov16_V3_SurgicalPatient.pdf
Uploaded 03/02/2017
ISRCTN39435140_PIS_19Sep16_V2_HealthyVolunteer.pdf
Uploaded 03/02/2017

Editorial Notes

16/01/2020: ClinicalTrials.gov number added. ClinicalTrials.gov stated that this trial was terminated by April 2019 as it had reached scientific goals, further recruitment would not further advance the findings of study.
28/03/2019: The condition has been changed from "Specialty: Gastroenterology, Primary sub-specialty: Gastroenterology; UKCRC code/ Disease: Oral and Gastrointestinal/ Other diseases of the digestive system, Metabolic and Endocrine/ Other nutritional deficiencies" to "Gastrointestinal surgery" following a request from the NIHR.
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.