Prevalence of metabolic obesity in patients with Barrett's Oesophagus and its potential role in carcinogenesis

ISRCTN	ISRCTN99001055
DOI	https://doi.org/10.1186/ISRCTN99001055
Secondary identifying numbers	v.2 06/01/2011

Submission date: 12/07/2011
Registration date: 05/01/2012
Last edited: 06/06/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://www.cancerresearchuk.org/cancer-help/trials/a-study-looking-obesity-people-barretts-oesophagus

Contact information

Dr Matthew Banks
Scientific

University College London Hospital
250 Euston Road
London
NW1 2BU
United Kingdom

Phone	+44 20 7380 9419
Email	matthew.banks@uclh.nhs.uk

Study information

Study design	Single centre non-randomised controlled trial
Primary study design	Observational
Secondary study design	Non randomised controlled trial
Study setting(s)	Hospital
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Prevalence of metabolic obesity in patients with Barrett's Oesophagus and its potential role in carcinogenesis: a single centre non-randomised controlled trial
Study objectives	The aim of this study is to investigate whether there is a connection between obesity and the development of Barrett's Oesophagus.
Ethics approval(s)	East Central London Research Ethics Committee, 09/02/2011, ref: 10/H0721/83
Health condition(s) or problem(s) studied	Barrett's Oesophagus and metabolic obesity
Intervention	The study will be divided in 2 phases (total duration 12 months): Phase 1: Recruitment, collection of data, endoscopy (OGD) biopsy and histology, blood tests (duration 8 months). 1. Subjects with known Barretts Oesophagus will be recruited from patients booked to have an OGD on a list dedicated to a Barretts oesophagus surveillance programme undertaken at University College Hospital, UK. 2. The control group will be recruited from patients booked to have an elective OGD for other gastrointestinal indications (negative at endoscopy for Barretts Oesophagus). Phase 2: Gata collection and analysis (duration 4 months) 1. Data will be entered into a database 2. Data analysis The prevalence of obesity, overweight and metabolic obesity will be determined. Anthropometric measurements and body composition (bioimpedance) and biochemical indices of metabolic syndrome will be measured. In those subjects with Barrett's Oesophagus histological presence of metaplasia/dysplasia will also be assessed.
Intervention type	Other
Primary outcome measure	Prevalence of overweight, obesity, and metabolic obesity in subjects with Barrett's Oesophagus as compared to subjects without Barrett's Oesophagus (standardised for age and sex). All the measures will be done only once at baseline, when patients attend their endoscopy test as part of their clinical management. No follow-up is required.
Secondary outcome measures	1. The characteristics of body composition, metabolic parameters and serum level of adiponectin/leptin in obese, overweight and metabolic obese subjects compared to those of normal weight. 2. The prevalence of abdominal obesity (in obese and overweight subjects) and metabolic obesity in subjects with dysplastic Barrett's oesophagus compared to those without dysplasia. All the measures will be done only once at baseline, when patients attend their endoscopy test as part of their clinical management. No follow-up is required.
Overall study start date	01/05/2011
Completion date	30/05/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	A total of 460 subjects will be recruited: 230 with known Barrett's Oesophagus and 230 without Barrett's Oesophagus
Key inclusion criteria	1. Able to understand the nature and requirements of the study and to provide written informed consent 2. Aged 18 - 79 years 3. Booked to undergo routine oesophagogastroduodenoscopy
Key exclusion criteria	1. Weight loss of more than 10% in the last year 2. Known decompensated liver disease 3. Coeliac disease 4. Inflammatory bowel disease 5. Previous upper gastrointestinal tract surgery 6. Known malignancy or undergoing treatment for previously resected malignancy 7. Inability to provide informed consent
Date of first enrolment	01/05/2011
Date of final enrolment	30/04/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University College London Hospital

London
NW1 2BU
United Kingdom

Sponsor information

University College London Hospital [UCLH] (UK)
University/education

c/o Dr Philip Diamond
Research and Development Department
Rosenheim Building
25 Grafton Way
London
WC1E 6DB
England
United Kingdom

Phone	+44 (0)20 7380 9833
Email	philip.diamond@uclh.nhs.uk
Website	http://www.uclh.org/
"ROR"	https://ror.org/02jx3x895

Funders

Funder type

Charity

University College London Hospital (UCLH) Charities - Clinical Research and Development Committee (CRDC) (UK) ref: GCT/2011/MB-Po

No information available

Results and Publications

Intention to publish date	01/03/2016
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in a peer reviewed journal.
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2016		Yes	No

Editorial Notes

06/06/2016: The recruitment end date have been updated from 30/04/2012 to 30/05/2013. Additionally, the availability of the participant level data has been added.
11/05/2016: Publication reference added.